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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119121688 | 11912168 | 8 | F | 201511 | 20160804 | 20160112 | 20160808 | EXP | CA-ROCHE-1657809 | ROCHE | 67.68 | YR | F | Y | 70.00000 | KG | 20160808 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119121688 | 11912168 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2049,B2035,B2052,B2055,B2035,B2050 | 125276 | 560 | MG | SOLUTION FOR INFUSION | |||||||
119121688 | 11912168 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2049,B2035,B2052,B2055,B2035,B2050 | 125276 | 600 | MG | SOLUTION FOR INFUSION | |||||||
119121688 | 11912168 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
119121688 | 11912168 | 4 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
119121688 | 11912168 | 5 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
119121688 | 11912168 | 1 | Rheumatoid arthritis |
119121688 | 11912168 | 3 | Product used for unknown indication |
119121688 | 11912168 | 4 | Product used for unknown indication |
119121688 | 11912168 | 5 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
119121688 | 11912168 | HO |
119121688 | 11912168 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
119121688 | 11912168 | Arthralgia | |
119121688 | 11912168 | Asthenia | |
119121688 | 11912168 | Blood pressure increased | |
119121688 | 11912168 | Cystitis | |
119121688 | 11912168 | Dyspnoea | |
119121688 | 11912168 | Fatigue | |
119121688 | 11912168 | Gait disturbance | |
119121688 | 11912168 | Gastric infection | |
119121688 | 11912168 | Gastroenteritis viral | |
119121688 | 11912168 | Gastrooesophageal reflux disease | |
119121688 | 11912168 | Heart rate decreased | |
119121688 | 11912168 | Hernia | |
119121688 | 11912168 | Joint swelling | |
119121688 | 11912168 | Loss of consciousness | |
119121688 | 11912168 | Muscular weakness | |
119121688 | 11912168 | Nausea | |
119121688 | 11912168 | Oxygen saturation decreased | |
119121688 | 11912168 | Renal disorder | |
119121688 | 11912168 | Weight decreased | |
119121688 | 11912168 | 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 |
---|---|---|---|---|---|---|
119121688 | 11912168 | 1 | 20150910 | 0 | ||
119121688 | 11912168 | 2 | 20160318 | 20160714 | 0 |