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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611011 | 12761101 | 1 | I | 20160906 | 20160920 | 20160920 | EXP | IT-CIPLA LTD.-2016IT18477 | CIPLA | TALOTTA R, ATZENI F, PUTTINI PS. REACTIVATION OF OCCULT HEPATITIS B VIRUS INFECTION UNDER TREATMENT WITH ABATACEPT: A CASE REPORT. BMC PHARMACOLOGY AND TOXICOLOGY. 2016;17(17):1 TO 3 | 0.00 | Y | 0.00000 | 20160920 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611011 | 12761101 | 1 | PS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 127611011 | 12761101 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 10 MG/ WEEK | 0 | 10 | MG | ||||||||
| 127611011 | 12761101 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 15 MG/ WEEK | 0 | 15 | MG | ||||||||
| 127611011 | 12761101 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG PER DAY | U | U | 0 | 5 | MG | ||||||
| 127611011 | 12761101 | 5 | SS | Golimumab | GOLIMUMAB | 1 | Unknown | 50 MG, EVERY MONTH | Y | U | 0 | 50 | MG | ||||||
| 127611011 | 12761101 | 6 | SS | Abatacept | ABATACEPT | 1 | Intravenous (not otherwise specified) | 750 MG, ONCE MONTHLY | Y | U | 0 | 750 | MG | ||||||
| 127611011 | 12761101 | 7 | SS | Abatacept | ABATACEPT | 1 | Intravenous (not otherwise specified) | 750 MG,ONCE MONTHLY | Y | U | 0 | 750 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127611011 | 12761101 | 1 | Hepatitis B |
| 127611011 | 12761101 | 2 | Rheumatoid arthritis |
| 127611011 | 12761101 | 4 | Rheumatoid arthritis |
| 127611011 | 12761101 | 5 | Rheumatoid arthritis |
| 127611011 | 12761101 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127611011 | 12761101 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127611011 | 12761101 | Cough | |
| 127611011 | 12761101 | Hepatitis B | |
| 127611011 | 12761101 | Rheumatoid arthritis | |
| 127611011 | 12761101 | Tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127611011 | 12761101 | 1 | 201401 | 0 | ||
| 127611011 | 12761101 | 2 | 201012 | 0 | ||
| 127611011 | 12761101 | 3 | 201102 | 0 | ||
| 127611011 | 12761101 | 4 | 201012 | 0 | ||
| 127611011 | 12761101 | 5 | 201111 | 0 | ||
| 127611011 | 12761101 | 6 | 201201 | 0 |