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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1010093913 | 10100939 | 13 | F | 20130901 | 20160725 | 20140424 | 20160727 | EXP | CA-ROCHE-1276096 | ROCHE | 58.27 | YR | F | Y | 100.00000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1010093913 | 10100939 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | U | B20262,B20353,N3702 | 125276 | 400 | MG | SOLUTION FOR INFUSION | ||||||
| 1010093913 | 10100939 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H0762,N3702,N3708,N3722 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 1010093913 | 10100939 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 1010093913 | 10100939 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | |||||||||||
| 1010093913 | 10100939 | 5 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | 0 | ||||||||||||
| 1010093913 | 10100939 | 6 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 1010093913 | 10100939 | 7 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 1010093913 | 10100939 | 8 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | 0 | ||||||||||||
| 1010093913 | 10100939 | 9 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 1010093913 | 10100939 | 10 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 1010093913 | 10100939 | 11 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1010093913 | 10100939 | 1 | Rheumatoid arthritis |
| 1010093913 | 10100939 | 2 | Rheumatoid arthritis |
| 1010093913 | 10100939 | 3 | Product used for unknown indication |
| 1010093913 | 10100939 | 9 | Premedication |
| 1010093913 | 10100939 | 10 | Premedication |
| 1010093913 | 10100939 | 11 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1010093913 | 10100939 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1010093913 | 10100939 | Arthralgia | |
| 1010093913 | 10100939 | Contusion | |
| 1010093913 | 10100939 | Cough | |
| 1010093913 | 10100939 | Dyspnoea | |
| 1010093913 | 10100939 | Ear haemorrhage | |
| 1010093913 | 10100939 | Gastroenteritis viral | |
| 1010093913 | 10100939 | Heart rate increased | |
| 1010093913 | 10100939 | Infusion related reaction | |
| 1010093913 | 10100939 | Malaise | |
| 1010093913 | 10100939 | Nasopharyngitis | |
| 1010093913 | 10100939 | Otorrhoea | |
| 1010093913 | 10100939 | Oxygen saturation decreased | |
| 1010093913 | 10100939 | Pain in jaw | |
| 1010093913 | 10100939 | Tendonitis | |
| 1010093913 | 10100939 | Type 2 diabetes mellitus |
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 |
|---|---|---|---|---|---|---|
| 1010093913 | 10100939 | 1 | 20130812 | 20140410 | 0 | |
| 1010093913 | 10100939 | 2 | 20140708 | 0 | ||
| 1010093913 | 10100939 | 9 | 20140708 | 0 | ||
| 1010093913 | 10100939 | 10 | 20140708 | 0 | ||
| 1010093913 | 10100939 | 11 | 20140708 | 0 |