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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1058071512 | 10580715 | 12 | F | 201206 | 20160329 | 20141113 | 20160331 | EXP | CA-ROCHE-1118484 | ROCHE | 66.44 | YR | F | Y | 77.30000 | KG | 20160331 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1058071512 | 10580715 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DAY 1, 15 | 103705 | 1000 | MG | ||||||||
| 1058071512 | 10580715 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20061,B20051,B20091,B20071 | 125276 | 660 | MG | SOLUTION FOR INFUSION | |||||||
| 1058071512 | 10580715 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | RECENT DOSE ON 31/OCT/2014 | B20061,B20051,B20091,B20071 | 125276 | SOLUTION FOR INFUSION | ||||||||
| 1058071512 | 10580715 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 1058071512 | 10580715 | 5 | C | BISOPROLOL | BISOPROLOL | 1 | 0 | ||||||||||||
| 1058071512 | 10580715 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 1058071512 | 10580715 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | /month | ||||||||||
| 1058071512 | 10580715 | 8 | C | ACTONEL | RISEDRONATE SODIUM | 1 | 0 | ||||||||||||
| 1058071512 | 10580715 | 9 | C | HALIBUT LIVER OIL | HALIBUT LIVER OIL | 1 | Oral | 0 | |||||||||||
| 1058071512 | 10580715 | 10 | C | DIGOXIN. | DIGOXIN | 1 | 0 | ||||||||||||
| 1058071512 | 10580715 | 11 | C | METHOTREXATE | METHOTREXATE | 1 | 0 | ||||||||||||
| 1058071512 | 10580715 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 1058071512 | 10580715 | 13 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1058071512 | 10580715 | 1 | Rheumatoid arthritis |
| 1058071512 | 10580715 | 2 | Rheumatoid arthritis |
| 1058071512 | 10580715 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1058071512 | 10580715 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1058071512 | 10580715 | Anxiety | |
| 1058071512 | 10580715 | Blood pressure fluctuation | |
| 1058071512 | 10580715 | Blood pressure increased | |
| 1058071512 | 10580715 | Bronchitis | |
| 1058071512 | 10580715 | Diarrhoea | |
| 1058071512 | 10580715 | Dyspnoea | |
| 1058071512 | 10580715 | Erythema | |
| 1058071512 | 10580715 | Eye disorder | |
| 1058071512 | 10580715 | Eyelid oedema | |
| 1058071512 | 10580715 | Fall | |
| 1058071512 | 10580715 | Fibromyalgia | |
| 1058071512 | 10580715 | Haemoglobin decreased | |
| 1058071512 | 10580715 | Headache | |
| 1058071512 | 10580715 | Heart rate irregular | |
| 1058071512 | 10580715 | Infusion related reaction | |
| 1058071512 | 10580715 | Lower respiratory tract infection | |
| 1058071512 | 10580715 | Malaise | |
| 1058071512 | 10580715 | Nasopharyngitis | |
| 1058071512 | 10580715 | Pain in extremity | |
| 1058071512 | 10580715 | Pharyngeal ulceration | |
| 1058071512 | 10580715 | Pneumonia | |
| 1058071512 | 10580715 | Radius fracture | |
| 1058071512 | 10580715 | Rheumatoid arthritis | |
| 1058071512 | 10580715 | Rotator cuff syndrome | |
| 1058071512 | 10580715 | Skin ulcer | |
| 1058071512 | 10580715 | Soft tissue injury | |
| 1058071512 | 10580715 | Stomatitis | |
| 1058071512 | 10580715 | Swelling face | |
| 1058071512 | 10580715 | Weight decreased | |
| 1058071512 | 10580715 | 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 |
|---|---|---|---|---|---|---|
| 1058071512 | 10580715 | 1 | 20150330 | 0 | ||
| 1058071512 | 10580715 | 2 | 20120530 | 20121031 | 0 | |
| 1058071512 | 10580715 | 12 | 20120625 | 0 |