Table 5.
Drug-event combinations commonly signaled by GPS for etanercept, infliximab and paroxetine hydrochloride in the Japanese Adverse Drug Event Report database and US Food and Drug Administration Adverse Event Reporting System for 2010
| Common DECs between JP and F-JP
|
Common signaled drug-event combinations (n)
|
|||||||
|---|---|---|---|---|---|---|---|---|
| MedDRA preferred term (code) | Listed | EB05
|
JP F-JP |
JP F-US |
F-JP F-US |
|||
| JP | F-JP | F-US | ||||||
| Etanercept | Extranodal marginal zone B-cell lymphoma (MALT type) (10061850) | W | 23.09 | 15.02 | N/A | 7 | 1 | 2 |
| Gastric cancer (10017758) | W | 5.06 | 2.16 | N/A | ||||
| Herpes zoster (10019974) | ADR | 2.28 | 2.24 | 2.37 | ||||
| Interstitial lung disease (10022611) | ADR | 2.79 | 2.43 | N/A | ||||
| Organizing pneumonia (10067472) | U | 4.06 | 4.83 | N/A | ||||
| Pneumocystis jiroveci pneumonia (10064108) | ADR | 2.25 | 2.38 | N/A | ||||
| Pneumonia pneumococcal (10035728) | ADR | 2.08 | 2.50 | N/A | ||||
| Infliximab | Disseminated tuberculosis (10013453) | ADR | 4.59 | 20.51 | N/A | 9 | 6 | 5 |
| Herpes zoster (10019974) | ADR | 2.35 | 2.17 | N/A | ||||
| Infusion-related reaction (10051792) | ADR | 25.56 | 34.47 | 42.87 | ||||
| Lupus-like syndrome (10050551) | ADR | 5.46 | 11.30 | 42.87 | ||||
| Peritoneal tuberculosis (10053583) | W | 43.44 | 24.08 | N/A | ||||
| Pneumocystis jiroveci pneumonia (10064108) | ADR | 16.05 | 15.67 | N/A | ||||
| Pneumonia bacterial (10060946) | ADR | 7.67 | 2.16 | N/A | ||||
| Pulmonary tuberculosis (10037440) | W | 19.44 | 28.01 | 4.16 | ||||
| Tuberculous pleurisy (10045104) | ADR | 20.64 | 28.05 | N/A | ||||
| Paroxetine hydrochloride | Activation syndrome (10066817) | ADR | 52.82 | 17.95 | N/A | 12 | 2 | 1 |
| Aggression (10001488) | W | 34.11 | 15.53 | N/A | ||||
| Anxiety (10002855) | ADR | 2.39 | 7.17 | N/A | ||||
| Completed suicide (10010144) | W | 8.44 | 2.67 | N/A | ||||
| Drug withdrawal syndrome (10013754) | W | 4.69 | 27.97 | N/A | ||||
| Drug withdrawal syndrome neonatal (10013756) | W | 2.92 | 17.45 | N/A | ||||
| Inappropriate ADH secretion (10053198) | ADR | 4.68 | 2.09 | N/A | ||||
| Irritability (10022998) | W | 2.91 | 13.56 | N/A | ||||
| Mania (10026749) | ADR | 3.37 | 2.95 | N/A | ||||
| Parkinsonism (10034010) | I | 8.33 | 3.08 | N/A | ||||
| Parkinson’s disease (10061536) | I | 16.66 | 9.76 | N/A | ||||
| Serotonin syndrome (10040108) | ADR | 13.18 | 11.44 | 2.45 | ||||
Abbreviations: ADH, antidiuretic hormone; ADR, listed in the section “adverse drug reaction”; I, interaction; U, unlisted; W, listed in the section “warning”, including contraindications and special populations; JP, Japanese cases reported to the Japanese authority; F-JP, Japanese cases reported to the FDA; F-US, US cases reported to the FDA; FDA, US Food and Drug Administration; N/A, not available; MALT, mucosa-associated lymphoid tissue.