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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125386014 | 12538601 | 4 | F | 20140708 | 20160803 | 20160708 | 20160805 | EXP | CA-ROCHE-1419490 | ROCHE | 22.19 | YR | M | Y | 81.00000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125386014 | 12538601 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | SOLUTION FOR INFUSION | |||||||||
| 125386014 | 12538601 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | SOLUTION FOR INFUSION | QOW | ||||||||
| 125386014 | 12538601 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | 680 | MG | SOLUTION FOR INFUSION | QOW | ||||||
| 125386014 | 12538601 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | 656 | MG | SOLUTION FOR INFUSION | QOW | ||||||
| 125386014 | 12538601 | 5 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | 640 | MG | SOLUTION FOR INFUSION | QOW | ||||||
| 125386014 | 12538601 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | SOLUTION FOR INFUSION | |||||||||
| 125386014 | 12538601 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2043B04,B2048B16,B2033B07,B2032B14 | 125276 | 648 | MG | SOLUTION FOR INFUSION | QOW | ||||||
| 125386014 | 12538601 | 8 | SS | CEPHALEXIN. | CEPHALEXIN | 1 | Oral | 0 | |||||||||||
| 125386014 | 12538601 | 9 | C | NAPROSYN | NAPROXEN | 1 | 17581 | ||||||||||||
| 125386014 | 12538601 | 10 | C | LOSEC | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 125386014 | 12538601 | 11 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 125386014 | 12538601 | 12 | C | AERIUS (CANADA) | 2 | 0 | |||||||||||||
| 125386014 | 12538601 | 13 | C | FUCIDIN | FUSIDIC ACID | 1 | Topical | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125386014 | 12538601 | 1 | Juvenile idiopathic arthritis |
| 125386014 | 12538601 | 8 | Localised infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125386014 | 12538601 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125386014 | 12538601 | Blister | |
| 125386014 | 12538601 | Blood pressure fluctuation | |
| 125386014 | 12538601 | Blood pressure increased | |
| 125386014 | 12538601 | Body temperature decreased | |
| 125386014 | 12538601 | Ear infection | |
| 125386014 | 12538601 | Gallbladder disorder | |
| 125386014 | 12538601 | Heart rate decreased | |
| 125386014 | 12538601 | Hypersensitivity | |
| 125386014 | 12538601 | Hypotension | |
| 125386014 | 12538601 | Infusion related reaction | |
| 125386014 | 12538601 | Juvenile idiopathic arthritis | |
| 125386014 | 12538601 | Lethargy | |
| 125386014 | 12538601 | Localised infection | |
| 125386014 | 12538601 | Nasopharyngitis | |
| 125386014 | 12538601 | Oropharyngeal pain | |
| 125386014 | 12538601 | Poor venous access | |
| 125386014 | 12538601 | Rash | |
| 125386014 | 12538601 | Weight decreased | |
| 125386014 | 12538601 | 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 |
|---|---|---|---|---|---|---|
| 125386014 | 12538601 | 1 | 2009 | 0 | ||
| 125386014 | 12538601 | 2 | 20131120 | 0 | ||
| 125386014 | 12538601 | 3 | 20131205 | 0 | ||
| 125386014 | 12538601 | 4 | 20140708 | 0 | ||
| 125386014 | 12538601 | 5 | 20140805 | 0 | ||
| 125386014 | 12538601 | 6 | 20141119 | 0 | ||
| 125386014 | 12538601 | 7 | 20150310 | 0 |