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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122615317 | 12261531 | 7 | F | 20151216 | 20160811 | 20160412 | 20160815 | EXP | CA-ROCHE-1679510 | ROCHE | 75.33 | YR | F | Y | 57.70000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122615317 | 12261531 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE: 20/MAY/2016 | B2047,B2048,B2058,B2039,B2059,B2060 | 125276 | 200 | MG | SOLUTION FOR INFUSION | ||||||
| 122615317 | 12261531 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2047,B2048,B2058,B2039,B2059,B2060 | 125276 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||||
| 122615317 | 12261531 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2047,B2048,B2058,B2039,B2059,B2060 | 125276 | 464 | MG | SOLUTION FOR INFUSION | |||||||
| 122615317 | 12261531 | 4 | C | TOLOXIN (CANADA) | 2 | 0 | |||||||||||||
| 122615317 | 12261531 | 5 | C | BISOPROLOL | BISOPROLOL | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 6 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 8 | C | EURO-FOLIC | 2 | 0 | |||||||||||||
| 122615317 | 12261531 | 9 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 10 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 11 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 122615317 | 12261531 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122615317 | 12261531 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122615317 | 12261531 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122615317 | 12261531 | Arthralgia | |
| 122615317 | 12261531 | Blood pressure diastolic decreased | |
| 122615317 | 12261531 | Diarrhoea | |
| 122615317 | 12261531 | Drug ineffective | |
| 122615317 | 12261531 | Dry throat | |
| 122615317 | 12261531 | Ill-defined disorder | |
| 122615317 | 12261531 | Inflammation | |
| 122615317 | 12261531 | Nausea | |
| 122615317 | 12261531 | Nocturia | |
| 122615317 | 12261531 | Pain | |
| 122615317 | 12261531 | Pain in extremity | |
| 122615317 | 12261531 | Rhinorrhoea | |
| 122615317 | 12261531 | Skin cancer | |
| 122615317 | 12261531 | Urinary incontinence | |
| 122615317 | 12261531 | Vomiting | |
| 122615317 | 12261531 | 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 |
|---|---|---|---|---|---|---|
| 122615317 | 12261531 | 1 | 20151118 | 0 | ||
| 122615317 | 12261531 | 3 | 20160309 | 0 |