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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288001 | 12528800 | 1 | I | 2012 | 20150303 | 20160705 | 20160705 | EXP | CA-PFIZER INC-2015080773 | PFIZER | 70.00 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288001 | 12528800 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 25 MG | Y | 11719 | 25 | MG | |||||||
| 125288001 | 12528800 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 12.5 MG, WEEKLY | Y | 11719 | 12.5 | MG | /wk | |||||||
| 125288001 | 12528800 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 10 MG, WEEKLY | Y | 11719 | 10 | MG | /wk | |||||||
| 125288001 | 12528800 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 7.5 MG, UNK | Y | 11719 | 7.5 | MG | ||||||||
| 125288001 | 12528800 | 5 | SS | ARAVA | LEFLUNOMIDE | 1 | 20 MG, 1X/DAY | Y | 0 | 20 | MG | QD | |||||||
| 125288001 | 12528800 | 6 | SS | ARAVA | LEFLUNOMIDE | 1 | DECREASING DOSE | Y | 0 | ||||||||||
| 125288001 | 12528800 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 400 MG, DAILY | Y | 0 | 400 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125288001 | 12528800 | 1 | Rheumatoid arthritis |
| 125288001 | 12528800 | 5 | Rheumatoid arthritis |
| 125288001 | 12528800 | 7 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125288001 | 12528800 | HO |
| 125288001 | 12528800 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125288001 | 12528800 | Blood pressure increased | |
| 125288001 | 12528800 | Condition aggravated | |
| 125288001 | 12528800 | Diarrhoea | |
| 125288001 | 12528800 | Drug ineffective | |
| 125288001 | 12528800 | Hepatic enzyme increased | |
| 125288001 | 12528800 | Nasopharyngitis | |
| 125288001 | 12528800 | Platelet count decreased | |
| 125288001 | 12528800 | Pneumonia | |
| 125288001 | 12528800 | Rheumatoid arthritis | |
| 125288001 | 12528800 | Weight increased | |
| 125288001 | 12528800 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125288001 | 12528800 | 1 | 201101 | 0 | ||
| 125288001 | 12528800 | 3 | 201411 | 0 | ||
| 125288001 | 12528800 | 4 | 201503 | 0 | ||
| 125288001 | 12528800 | 5 | 201103 | 0 | ||
| 125288001 | 12528800 | 6 | 2012 | 201205 | 0 | |
| 125288001 | 12528800 | 7 | 201411 | 201503 | 0 |