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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113599499 | 11359949 | 9 | F | 20121120 | 20160915 | 20150810 | 20160919 | EXP | CA-ROCHE-1150809 | ROCHE | 77.69 | YR | F | Y | 49.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113599499 | 11359949 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | RPAP DOSE | B20071,B20112,B20162,B20243,B20383, | 125276 | 204 | MG | SOLUTION FOR INFUSION | ||||||
| 113599499 | 11359949 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20071,B20112,B20162,B20243,B20383, | 125276 | 224 | MG | SOLUTION FOR INFUSION | |||||||
| 113599499 | 11359949 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B20071,B20112,B20162,B20243,B20383, | 125276 | 220 | MG | SOLUTION FOR INFUSION | |||||||
| 113599499 | 11359949 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | U | 0 | ||||||||||
| 113599499 | 11359949 | 5 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 113599499 | 11359949 | 6 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Unknown | 0 | 70 | MG | |||||||||
| 113599499 | 11359949 | 7 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | 0 | 20 | MG | |||||||||
| 113599499 | 11359949 | 8 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 0 | 10 | MG | QD | ||||||||
| 113599499 | 11359949 | 9 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 113599499 | 11359949 | 10 | C | INDAPAMIDE. | INDAPAMIDE | 1 | Unknown | 0 | 1.25 | MG | |||||||||
| 113599499 | 11359949 | 11 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | .05 | MG | |||||||||
| 113599499 | 11359949 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | 5 | MG | |||||||||
| 113599499 | 11359949 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 113599499 | 11359949 | 14 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 0 | 400 | IU | |||||||||
| 113599499 | 11359949 | 15 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | 7.5 | MG | TABLET | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113599499 | 11359949 | 1 | Rheumatoid arthritis |
| 113599499 | 11359949 | 4 | Product used for unknown indication |
| 113599499 | 11359949 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113599499 | 11359949 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113599499 | 11359949 | Arthralgia | |
| 113599499 | 11359949 | Arthritis | |
| 113599499 | 11359949 | Back pain | |
| 113599499 | 11359949 | Body temperature decreased | |
| 113599499 | 11359949 | Conjunctival hyperaemia | |
| 113599499 | 11359949 | Contusion | |
| 113599499 | 11359949 | Eye discharge | |
| 113599499 | 11359949 | Eye pain | |
| 113599499 | 11359949 | Fall | |
| 113599499 | 11359949 | Furuncle | |
| 113599499 | 11359949 | Gastroenteritis viral | |
| 113599499 | 11359949 | Haematoma | |
| 113599499 | 11359949 | Headache | |
| 113599499 | 11359949 | Heart rate irregular | |
| 113599499 | 11359949 | Infusion related reaction | |
| 113599499 | 11359949 | International normalised ratio increased | |
| 113599499 | 11359949 | Joint swelling | |
| 113599499 | 11359949 | Limb injury | |
| 113599499 | 11359949 | Mobility decreased | |
| 113599499 | 11359949 | Nasopharyngitis | |
| 113599499 | 11359949 | Ocular discomfort | |
| 113599499 | 11359949 | Oedema | |
| 113599499 | 11359949 | Oral herpes | |
| 113599499 | 11359949 | Oral pain | |
| 113599499 | 11359949 | Pain | |
| 113599499 | 11359949 | Scratch | |
| 113599499 | 11359949 | Tooth fracture | |
| 113599499 | 11359949 | Toothache | |
| 113599499 | 11359949 | Weight decreased | |
| 113599499 | 11359949 | Weight increased | |
| 113599499 | 11359949 | Wound secretion |
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 |
|---|---|---|---|---|---|---|
| 113599499 | 11359949 | 1 | 20120926 | 0 | ||
| 113599499 | 11359949 | 2 | 20140924 | 0 | ||
| 113599499 | 11359949 | 3 | 20160525 | 0 |