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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121394693 | 12139469 | 3 | F | 20121119 | 20160823 | 20160303 | 20160825 | EXP | CA-ROCHE-1162790 | ROCHE | 43.06 | YR | F | Y | 65.00000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121394693 | 12139469 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20121,B20071,B20151,B20353,B20192, | 125276 | 440 | MG | SOLUTION FOR INFUSION | |||||||
| 121394693 | 12139469 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20121,B20071,B20151,B20353,B20192, | 125276 | 464 | MG | SOLUTION FOR INFUSION | |||||||
| 121394693 | 12139469 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20121,B20071,B20151,B20353,B20192, | 125276 | 440 | MG | SOLUTION FOR INFUSION | |||||||
| 121394693 | 12139469 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20121,B20071,B20151,B20353,B20192, | 125276 | 520 | MG | SOLUTION FOR INFUSION | |||||||
| 121394693 | 12139469 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 121394693 | 12139469 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121394693 | 12139469 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121394693 | 12139469 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121394693 | 12139469 | Amenorrhoea | |
| 121394693 | 12139469 | Anxiety | |
| 121394693 | 12139469 | Blood pressure increased | |
| 121394693 | 12139469 | Burn oral cavity | |
| 121394693 | 12139469 | Dehydration | |
| 121394693 | 12139469 | Gastrooesophageal reflux disease | |
| 121394693 | 12139469 | Infusion related reaction | |
| 121394693 | 12139469 | Lower respiratory tract infection | |
| 121394693 | 12139469 | Menstruation irregular | |
| 121394693 | 12139469 | Nasopharyngitis | |
| 121394693 | 12139469 | Sensitivity of teeth | |
| 121394693 | 12139469 | 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 |
|---|---|---|---|---|---|---|
| 121394693 | 12139469 | 1 | 20110613 | 0 | ||
| 121394693 | 12139469 | 2 | 20130821 | 0 | ||
| 121394693 | 12139469 | 3 | 20150427 | 0 | ||
| 121394693 | 12139469 | 4 | 20150707 | 0 |