Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126597291 | 12659729 | 1 | I | 20160809 | 20160817 | 20160817 | EXP | PHHY2016JP110477 | SANDOZ | KOMURA T, OHTA H, NAKAI R, SEISHIMA J, YAMATO M, MIYAZAWA M, ET AL. CYTOMEGALOVIRUS REACTIVATION INDUCED ACUTE HEPATITIS AND GASTRIC EROSIONS IN A PATIENT WITH RHEUMATOID ARTHRITIS UNDER TREATMENT WITH AN ANTI-IL-6 RECEPTOR ANTIBODY, TOCILIZUMAB. INTERNAL MEDICINE. 2016;55(14):1923-927 | 54.00 | YR | F | Y | 0.00000 | 20160817 | OT | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126597291 | 12659729 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 8 MG, QW | 90029 | 8 | MG | /wk | |||||||
| 126597291 | 12659729 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 126597291 | 12659729 | 3 | SS | TOCILIZUMAB | TOCILIZUMAB | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126597291 | 12659729 | 1 | Rheumatoid arthritis |
| 126597291 | 12659729 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126597291 | 12659729 | OT |
| 126597291 | 12659729 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126597291 | 12659729 | Cytomegalovirus infection | |
| 126597291 | 12659729 | Drug ineffective | |
| 126597291 | 12659729 | Gastritis erosive | |
| 126597291 | 12659729 | Hepatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |