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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124338093 | 12433809 | 3 | F | 201512 | 20160808 | 20160603 | 20160816 | EXP | US-JNJFOC-20160527493 | JANSSEN | 49.14 | YR | A | M | Y | 81.65000 | KG | 20160816 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124338093 | 12433809 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | 103772 | LYOPHILIZED POWDER | ||||||||
| 124338093 | 12433809 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | N | 0 | UNSPECIFIED | |||||||||
| 124338093 | 12433809 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 2 YEARS | U | 0 | UNSPECIFIED | ||||||||
| 124338093 | 12433809 | 4 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Unknown | U | 0 | 5 | MG | UNSPECIFIED | BID | ||||||
| 124338093 | 12433809 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 15 | MG | UNSPECIFIED | QD | |||||||
| 124338093 | 12433809 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 15 | MG | UNSPECIFIED | QD | |||||||
| 124338093 | 12433809 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 15 | MG | UNSPECIFIED | QD | |||||||
| 124338093 | 12433809 | 8 | C | MOTRIN | IBUPROFEN | 1 | Unknown | 0 | 800 | MG | UNSPECIFIED | QID | |||||||
| 124338093 | 12433809 | 9 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | 650 | MG | UNSPECIFIED | BID | |||||||
| 124338093 | 12433809 | 10 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124338093 | 12433809 | 1 | Product used for unknown indication |
| 124338093 | 12433809 | 2 | Rheumatoid arthritis |
| 124338093 | 12433809 | 3 | Rheumatoid arthritis |
| 124338093 | 12433809 | 4 | Rheumatoid arthritis |
| 124338093 | 12433809 | 5 | Rheumatoid arthritis |
| 124338093 | 12433809 | 6 | Inflammation |
| 124338093 | 12433809 | 7 | Pain |
| 124338093 | 12433809 | 8 | Inflammation |
| 124338093 | 12433809 | 9 | Pain |
| 124338093 | 12433809 | 10 | Gastrointestinal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124338093 | 12433809 | HO |
| 124338093 | 12433809 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124338093 | 12433809 | Alopecia | |
| 124338093 | 12433809 | Cardiac disorder | |
| 124338093 | 12433809 | Chest pain | |
| 124338093 | 12433809 | Chills | |
| 124338093 | 12433809 | Headache | |
| 124338093 | 12433809 | Infusion related reaction | |
| 124338093 | 12433809 | Rash generalised | |
| 124338093 | 12433809 | Rheumatoid arthritis | |
| 124338093 | 12433809 | 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 |
|---|---|---|---|---|---|---|
| 124338093 | 12433809 | 1 | 2013 | 0 | ||
| 124338093 | 12433809 | 4 | 201509 | 2016 | 0 | |
| 124338093 | 12433809 | 5 | 2014 | 0 | ||
| 124338093 | 12433809 | 6 | 2014 | 0 | ||
| 124338093 | 12433809 | 7 | 2014 | 0 | ||
| 124338093 | 12433809 | 8 | 2009 | 201605 | 0 | |
| 124338093 | 12433809 | 9 | 2009 | 0 | ||
| 124338093 | 12433809 | 10 | 2010 | 0 |