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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121264115 | 12126411 | 5 | F | 201601 | 20160725 | 20160229 | 20160801 | EXP | BR-JNJFOC-20160226159 | JANSSEN | 60.60 | YR | A | F | Y | 58.00000 | KG | 20160801 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121264115 | 12126411 | 1 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION | |||||||||
| 121264115 | 12126411 | 2 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | N | 125289 | SOLUTION FOR INJECTION | |||||||||
| 121264115 | 12126411 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 121264115 | 12126411 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 121264115 | 12126411 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 121264115 | 12126411 | 6 | C | RIVOTRIL | CLONAZEPAM | 1 | Unknown | 0 | |||||||||||
| 121264115 | 12126411 | 7 | C | PONDERA | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 121264115 | 12126411 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121264115 | 12126411 | 1 | Rheumatoid arthritis |
| 121264115 | 12126411 | 2 | Rheumatoid arthritis |
| 121264115 | 12126411 | 3 | Product used for unknown indication |
| 121264115 | 12126411 | 4 | Product used for unknown indication |
| 121264115 | 12126411 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121264115 | 12126411 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121264115 | 12126411 | Alopecia | |
| 121264115 | 12126411 | Arthralgia | |
| 121264115 | 12126411 | Asthenia | |
| 121264115 | 12126411 | Blindness | |
| 121264115 | 12126411 | Depression | |
| 121264115 | 12126411 | Exostosis | |
| 121264115 | 12126411 | Headache | |
| 121264115 | 12126411 | Herpes virus infection | |
| 121264115 | 12126411 | Hypotension | |
| 121264115 | 12126411 | Impaired work ability | |
| 121264115 | 12126411 | Malaise | |
| 121264115 | 12126411 | Memory impairment | |
| 121264115 | 12126411 | Pneumonia | |
| 121264115 | 12126411 | Rheumatoid arthritis | |
| 121264115 | 12126411 | Spinal pain | |
| 121264115 | 12126411 | Vomiting | |
| 121264115 | 12126411 | Weight decreased | |
| 121264115 | 12126411 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 121264115 | 12126411 | 1 | 20150424 | 0 | ||
| 121264115 | 12126411 | 2 | 20160302 | 0 |