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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107539586 | 10753958 | 6 | F | 201409 | 20160912 | 20150202 | 20160920 | EXP | CA-ROCHE-1455520 | ROCHE | 44.10 | YR | F | Y | 0.00000 | 20160920 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107539586 | 10753958 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 728 | MG | SOLUTION FOR INFUSION | ||||||||
| 107539586 | 10753958 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 752.8 | MG | SOLUTION FOR INFUSION | ||||||||
| 107539586 | 10753958 | 3 | SS | SULFAMETHOXAZOLE/TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | 0 | ||||||||||
| 107539586 | 10753958 | 4 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 107539586 | 10753958 | 5 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 107539586 | 10753958 | 6 | SS | CHLORHEXIDINE | CHLORHEXIDINE | 1 | Unknown | U | 0 | ||||||||||
| 107539586 | 10753958 | 7 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | U | 0 | ||||||||||
| 107539586 | 10753958 | 8 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | U | 0 | ||||||||||
| 107539586 | 10753958 | 9 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 107539586 | 10753958 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | ||||||||||
| 107539586 | 10753958 | 11 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 107539586 | 10753958 | 12 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 107539586 | 10753958 | 13 | C | PREDNISONE. | PREDNISONE | 1 | Oral | DOSE LOWERED | 0 | QD | |||||||||
| 107539586 | 10753958 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | DAILY (DOSE INCREASED) | 0 | 7.5 | MG | ||||||||
| 107539586 | 10753958 | 15 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 107539586 | 10753958 | 16 | C | DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTRELETHINYL ESTRADIOL | 1 | 0 | ||||||||||||
| 107539586 | 10753958 | 17 | C | REACTINE (CANADA) | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | BID | ||||||||
| 107539586 | 10753958 | 18 | C | TYLENOL #1 (CANADA) | ACETAMINOPHENCAFFEINECODEINE PHOSPHATE | 1 | Unknown | FREQUENCY TIME : AS REQUIRED. | 0 | ||||||||||
| 107539586 | 10753958 | 19 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | FREQUENCY TIME: AS REQUIRED. | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107539586 | 10753958 | 1 | Rheumatoid arthritis |
| 107539586 | 10753958 | 3 | Product used for unknown indication |
| 107539586 | 10753958 | 4 | Product used for unknown indication |
| 107539586 | 10753958 | 5 | Product used for unknown indication |
| 107539586 | 10753958 | 6 | Product used for unknown indication |
| 107539586 | 10753958 | 7 | Product used for unknown indication |
| 107539586 | 10753958 | 8 | Product used for unknown indication |
| 107539586 | 10753958 | 9 | Product used for unknown indication |
| 107539586 | 10753958 | 10 | Product used for unknown indication |
| 107539586 | 10753958 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107539586 | 10753958 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107539586 | 10753958 | Arthralgia | |
| 107539586 | 10753958 | Blister | |
| 107539586 | 10753958 | Contusion | |
| 107539586 | 10753958 | Drug effect decreased | |
| 107539586 | 10753958 | Drug ineffective | |
| 107539586 | 10753958 | Dyspnoea | |
| 107539586 | 10753958 | Fatigue | |
| 107539586 | 10753958 | Folliculitis | |
| 107539586 | 10753958 | Gastrointestinal disorder | |
| 107539586 | 10753958 | Hypersensitivity | |
| 107539586 | 10753958 | Impaired healing | |
| 107539586 | 10753958 | Infection | |
| 107539586 | 10753958 | Irritable bowel syndrome | |
| 107539586 | 10753958 | Joint swelling | |
| 107539586 | 10753958 | Lower respiratory tract infection | |
| 107539586 | 10753958 | Muscle injury | |
| 107539586 | 10753958 | Nasopharyngitis | |
| 107539586 | 10753958 | Peripheral swelling | |
| 107539586 | 10753958 | Pruritus | |
| 107539586 | 10753958 | Pyrexia | |
| 107539586 | 10753958 | Rash | |
| 107539586 | 10753958 | Sinusitis | |
| 107539586 | 10753958 | Sleep disorder due to general medical condition, insomnia type | |
| 107539586 | 10753958 | Stomatitis | |
| 107539586 | 10753958 | Swelling | |
| 107539586 | 10753958 | 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 |
|---|---|---|---|---|---|---|
| 107539586 | 10753958 | 1 | 20140729 | 0 | ||
| 107539586 | 10753958 | 2 | 20141216 | 20150309 | 0 | |
| 107539586 | 10753958 | 13 | 201404 | 0 |