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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 941604622 | 9416046 | 22 | F | 20130701 | 20160809 | 20130724 | 20160811 | EXP | CA-ROCHE-1251216 | ROCHE | 60.76 | YR | F | Y | 77.80000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 941604622 | 9416046 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | Y | U | B2011B232,B2019B242,B2016B262,B2021 | 125276 | 312 | MG | SOLUTION FOR INFUSION | |||||
| 941604622 | 9416046 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | Y | U | B2011B232,B2019B242,B2016B262,B2021 | 125276 | 320 | MG | SOLUTION FOR INFUSION | |||||
| 941604622 | 9416046 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N3702B02,N3708B01,N3722 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 941604622 | 9416046 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | |||||||||||
| 941604622 | 9416046 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | |||||||||
| 941604622 | 9416046 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Ophthalmic | 0 | 10 | MG | |||||||||
| 941604622 | 9416046 | 7 | C | ARAVA | LEFLUNOMIDE | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 8 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 9 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 10 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 11 | C | RAMIPRIL. | RAMIPRIL | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 12 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | QD | ||||||||||
| 941604622 | 9416046 | 13 | C | RABEPRAZOLE | RABEPRAZOLE | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 14 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 15 | C | IBUPROFEN. | IBUPROFEN | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 16 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 0 | 375 | MG | BID | ||||||||
| 941604622 | 9416046 | 17 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 0 | QD | ||||||||||
| 941604622 | 9416046 | 18 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 0 | QD | ||||||||||
| 941604622 | 9416046 | 19 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | QD | ||||||||||
| 941604622 | 9416046 | 20 | C | TYLENOL #1 (CANADA) | ACETAMINOPHENCAFFEINECODEINE PHOSPHATE | 1 | Oral | 0 | 650 | MG | |||||||||
| 941604622 | 9416046 | 21 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 941604622 | 9416046 | 22 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 941604622 | 9416046 | 23 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 941604622 | 9416046 | 24 | C | Glibenclamide | GLYBURIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 941604622 | 9416046 | 1 | Rheumatoid arthritis |
| 941604622 | 9416046 | 3 | Rheumatoid arthritis |
| 941604622 | 9416046 | 4 | Product used for unknown indication |
| 941604622 | 9416046 | 12 | Hypothyroidism |
| 941604622 | 9416046 | 16 | Rheumatoid arthritis |
| 941604622 | 9416046 | 17 | Rheumatoid arthritis |
| 941604622 | 9416046 | 19 | Dyslipidaemia |
| 941604622 | 9416046 | 20 | Premedication |
| 941604622 | 9416046 | 21 | Premedication |
| 941604622 | 9416046 | 22 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 941604622 | 9416046 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 941604622 | 9416046 | Abdominal distension | |
| 941604622 | 9416046 | Blood glucose increased | |
| 941604622 | 9416046 | Blood pressure increased | |
| 941604622 | 9416046 | Blood pressure systolic increased | |
| 941604622 | 9416046 | Cough | |
| 941604622 | 9416046 | Diabetes mellitus inadequate control | |
| 941604622 | 9416046 | Diarrhoea | |
| 941604622 | 9416046 | Drug effect decreased | |
| 941604622 | 9416046 | Dry eye | |
| 941604622 | 9416046 | Lung infection | |
| 941604622 | 9416046 | Osteoporosis | |
| 941604622 | 9416046 | Oxygen saturation decreased | |
| 941604622 | 9416046 | Rheumatoid arthritis | |
| 941604622 | 9416046 | Ulcerative keratitis |
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 |
|---|---|---|---|---|---|---|
| 941604622 | 9416046 | 1 | 20130306 | 0 | ||
| 941604622 | 9416046 | 2 | 20140107 | 20140501 | 0 | |
| 941604622 | 9416046 | 3 | 20140715 | 0 | ||
| 941604622 | 9416046 | 4 | 20140203 | 0 | ||
| 941604622 | 9416046 | 20 | 20140715 | 0 | ||
| 941604622 | 9416046 | 21 | 20140715 | 0 | ||
| 941604622 | 9416046 | 22 | 20140715 | 0 |