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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126770221 | 12677022 | 1 | I | 20151111 | 20160823 | 20160823 | EXP | CA-ROCHE-1660064 | ROCHE | 0.00 | F | Y | 0.00000 | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126770221 | 12677022 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | U | 103705 | SOLUTION FOR INFUSION | |||||||||
| 126770221 | 12677022 | 2 | SS | NAPROSYN | NAPROXEN | 1 | Oral | 1 TABLET 2 TIMES DAILY | U | 17581 | 500 | MG | TABLET | BID | |||||
| 126770221 | 12677022 | 3 | SS | NAPROSYN | NAPROXEN | 1 | Oral | 1 TABLET 2 TIMES DAILY | U | 17581 | 750 | MG | TABLET | BID | |||||
| 126770221 | 12677022 | 4 | SS | NAPROSYN | NAPROXEN | 1 | Oral | U | 17581 | 500 | MG | TABLET | BID | ||||||
| 126770221 | 12677022 | 5 | SS | NAPROSYN | NAPROXEN | 1 | Oral | U | 17581 | 500 | MG | TABLET | QD | ||||||
| 126770221 | 12677022 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125276 | 4 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 126770221 | 12677022 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | EVERY WEDNESDAY | U | 0 | 2.5 | MG | TABLET | ||||||
| 126770221 | 12677022 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | EVERY TUESDAY 5 TABLET ONCE A WEEK | U | 0 | 2.5 | MG | TABLET | ||||||
| 126770221 | 12677022 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | U | 0 | 25 | MG | /wk | |||||||
| 126770221 | 12677022 | 10 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | U | 0 | ||||||||||
| 126770221 | 12677022 | 11 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | 0 | 20 | MG | TABLET | |||||||
| 126770221 | 12677022 | 12 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | 1 TABLET 3 TIMES DAILY | U | 0 | 600 | MG | TABLET | TID | |||||
| 126770221 | 12677022 | 13 | SS | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 126770221 | 12677022 | 14 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 126770221 | 12677022 | 15 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | U | 0 | ||||||||||
| 126770221 | 12677022 | 16 | SS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | DELAYED RELEASE | U | 0 | 20 | MG | GASTRO-RESISTANT COATED TABLET | QID | |||||
| 126770221 | 12677022 | 17 | SS | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | U | 0 | 20 | MG | GASTRO-RESISTANT COATED TABLET | QID | ||||||
| 126770221 | 12677022 | 18 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Oral | 40MG V/L ONCE INJECTION 1ML | U | 0 | 40 | MG | |||||||
| 126770221 | 12677022 | 19 | SS | FOLIC ACID. | FOLIC ACID | 1 | Oral | EVERY FRIDAY | U | 0 | 5 | MG | TABLET | /wk | |||||
| 126770221 | 12677022 | 20 | SS | FOLIC ACID. | FOLIC ACID | 1 | Oral | EVERY WEDNESDAY 1 TABLET A WEEK | U | 0 | 5 | MG | TABLET | ||||||
| 126770221 | 12677022 | 21 | C | ARAVA | LEFLUNOMIDE | 1 | Unknown | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126770221 | 12677022 | 1 | Rheumatoid arthritis |
| 126770221 | 12677022 | 2 | Rheumatoid arthritis |
| 126770221 | 12677022 | 6 | Product used for unknown indication |
| 126770221 | 12677022 | 7 | Rheumatoid arthritis |
| 126770221 | 12677022 | 10 | Rheumatoid arthritis |
| 126770221 | 12677022 | 11 | Rheumatoid arthritis |
| 126770221 | 12677022 | 12 | Rheumatoid arthritis |
| 126770221 | 12677022 | 13 | Arthralgia |
| 126770221 | 12677022 | 14 | Rheumatoid arthritis |
| 126770221 | 12677022 | 16 | Product used for unknown indication |
| 126770221 | 12677022 | 18 | Product used for unknown indication |
| 126770221 | 12677022 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126770221 | 12677022 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126770221 | 12677022 | Blood alkaline phosphatase increased | |
| 126770221 | 12677022 | C-reactive protein increased | |
| 126770221 | 12677022 | Condition aggravated | |
| 126770221 | 12677022 | Drug hypersensitivity | |
| 126770221 | 12677022 | Drug ineffective | |
| 126770221 | 12677022 | Erythema | |
| 126770221 | 12677022 | Mouth ulceration | |
| 126770221 | 12677022 | Nasal ulcer | |
| 126770221 | 12677022 | Obesity | |
| 126770221 | 12677022 | Pain | |
| 126770221 | 12677022 | Pneumonia | |
| 126770221 | 12677022 | Stress | |
| 126770221 | 12677022 | Swelling | |
| 126770221 | 12677022 | Therapeutic response 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 |
|---|---|---|---|---|---|---|
| 126770221 | 12677022 | 2 | 20140613 | 0 | ||
| 126770221 | 12677022 | 3 | 20140925 | 0 | ||
| 126770221 | 12677022 | 4 | 20130702 | 0 | ||
| 126770221 | 12677022 | 6 | 201301 | 201310 | 0 | |
| 126770221 | 12677022 | 7 | 20140613 | 0 | ||
| 126770221 | 12677022 | 8 | 20131015 | 0 | ||
| 126770221 | 12677022 | 9 | 200910 | 201205 | 0 | |
| 126770221 | 12677022 | 11 | 200910 | 201302 | 0 | |
| 126770221 | 12677022 | 12 | 20140514 | 0 | ||
| 126770221 | 12677022 | 15 | 201001 | 201008 | 0 | |
| 126770221 | 12677022 | 16 | 20140613 | 0 | ||
| 126770221 | 12677022 | 17 | 20131015 | 0 | ||
| 126770221 | 12677022 | 18 | 20140409 | 0 | ||
| 126770221 | 12677022 | 19 | 20140613 | 0 | ||
| 126770221 | 12677022 | 20 | 20131015 | 0 | ||
| 126770221 | 12677022 | 21 | 200910 | 201302 | 0 |