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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127047471 | 12704747 | 1 | I | 20160829 | 20160831 | 20160831 | EXP | CA-MYLANLABS-2016M1036911 | MYLAN | 0.00 | Y | 0.00000 | 20160831 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127047471 | 12704747 | 1 | PS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG, QW | U | U | 201529 | 25 | MG | SOLUTION FOR INJECTION | /wk | ||||
| 127047471 | 12704747 | 2 | SS | FOLIC ACID. | FOLIC ACID | 1 | 2 DF, QW | U | U | 0 | 2 | DF | /wk | ||||||
| 127047471 | 12704747 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | U | 0 | |||||||||
| 127047471 | 12704747 | 4 | SS | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 40 MG, QD | U | U | 0 | 40 | MG | TABLET | QD | |||||
| 127047471 | 12704747 | 5 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 400 MG, QD | U | U | 0 | 400 | MG | TABLET | QD | |||||
| 127047471 | 12704747 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | 5 MG, QD | U | U | 0 | 5 | MG | QD | ||||||
| 127047471 | 12704747 | 7 | C | SULFASALAZINE. | SULFASALAZINE | 1 | U | 0 | |||||||||||
| 127047471 | 12704747 | 8 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 10 MG, QD | U | U | 0 | 10 | MG | TABLET | QD | ||||
| 127047471 | 12704747 | 9 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 10 MG, QD | U | U | 0 | 10 | MG | TABLET | QD | ||||
| 127047471 | 12704747 | 10 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, QD | U | U | 0 | 5 | MG | TABLET | QD | ||||
| 127047471 | 12704747 | 11 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | UNK | U | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127047471 | 12704747 | 1 | Rheumatoid arthritis |
| 127047471 | 12704747 | 2 | Rheumatoid arthritis |
| 127047471 | 12704747 | 3 | Product used for unknown indication |
| 127047471 | 12704747 | 4 | Product used for unknown indication |
| 127047471 | 12704747 | 5 | Rheumatoid arthritis |
| 127047471 | 12704747 | 6 | Product used for unknown indication |
| 127047471 | 12704747 | 8 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127047471 | 12704747 | HO |
| 127047471 | 12704747 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127047471 | 12704747 | Abdominal pain | |
| 127047471 | 12704747 | Asthenia | |
| 127047471 | 12704747 | Condition aggravated | |
| 127047471 | 12704747 | Diarrhoea | |
| 127047471 | 12704747 | Dizziness | |
| 127047471 | 12704747 | Fatigue | |
| 127047471 | 12704747 | Hernia | |
| 127047471 | 12704747 | Pneumonia | |
| 127047471 | 12704747 | Rheumatoid arthritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |