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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662641 | 12566264 | 1 | I | 20160705 | 20160718 | 20160718 | EXP | CA-HQ SPECIALTY-CA-2016INT000549 | INTERCHEM | 74.00 | YR | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662641 | 12566264 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 6 DOSAGE FORM, 1 IN 1 W | N | 201749 | 6 | DF | TABLET | ||||||
| 125662641 | 12566264 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 7 DOSAGE FORM, 1 IN 1 W | N | 201749 | 7 | DF | TABLET | ||||||
| 125662641 | 12566264 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Oral | 8 DOSAGE FORM, 1 IN 1 W | N | 201749 | 8 | DF | TABLET | ||||||
| 125662641 | 12566264 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | VARIOUS (1 D) | N | 0 | ||||||||||
| 125662641 | 12566264 | 5 | SS | ARAVA | LEFLUNOMIDE | 1 | VARIOUS (2 DOSAGE FORM, 1 D) | N | 0 | 2 | DF | ||||||||
| 125662641 | 12566264 | 6 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 2 TABS DAILY FROM MONDAY TO FRIDAY, 1 TAB DAILY ON | N | 0 | ||||||||||
| 125662641 | 12566264 | 7 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 2 DOSAGE FORM,1 IN 1 D | N | 0 | 2 | DF | ||||||||
| 125662641 | 12566264 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 6 DAYS PER WEEK EXCEPT DAY OF METHOTREXATE | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125662641 | 12566264 | 1 | Rheumatoid arthritis |
| 125662641 | 12566264 | 4 | Rheumatoid arthritis |
| 125662641 | 12566264 | 6 | Product used for unknown indication |
| 125662641 | 12566264 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125662641 | 12566264 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125662641 | 12566264 | Breast cancer | |
| 125662641 | 12566264 | Diarrhoea | |
| 125662641 | 12566264 | Drug ineffective | |
| 125662641 | 12566264 | Interstitial lung disease | |
| 125662641 | 12566264 | Mycobacterium tuberculosis complex test positive | |
| 125662641 | 12566264 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 125662641 | 12566264 | 1 | 20140818 | 2014 | 0 | |
| 125662641 | 12566264 | 2 | 2014 | 2014 | 0 | |
| 125662641 | 12566264 | 3 | 20141125 | 201502 | 0 | |
| 125662641 | 12566264 | 4 | 20150218 | 0 | ||
| 125662641 | 12566264 | 5 | 20150520 | 201505 | 0 | |
| 125662641 | 12566264 | 6 | 20141125 | 0 | ||
| 125662641 | 12566264 | 7 | 20150218 | 201505 | 0 | |
| 125662641 | 12566264 | 8 | 20141125 | 0 |