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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644061 | 12564406 | 1 | I | 20160205 | 20160205 | 20160718 | 20160718 | EXP | BR-ROCHE-1707491 | ROCHE | 62.03 | YR | F | Y | 75.00000 | KG | 20160718 | OT | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644061 | 12564406 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | (DAY 1) | Y | 103705 | 500 | MG | SOLUTION FOR INFUSION | ||||||
| 125644061 | 12564406 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | SOLUTION FOR INFUSION | |||||||||
| 125644061 | 12564406 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF RECENT RITUXIMAB INFUSION: 20/FEB/2016 | Y | 103705 | SOLUTION FOR INFUSION | ||||||||
| 125644061 | 12564406 | 4 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | 750 | MG | |||||||||
| 125644061 | 12564406 | 5 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Unknown | 0 | 2 | MG | |||||||||
| 125644061 | 12564406 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | .8 | MG | /wk | ||||||||
| 125644061 | 12564406 | 7 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 1 TABLET | 0 | 20 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125644061 | 12564406 | 1 | Rheumatoid arthritis |
| 125644061 | 12564406 | 4 | Premedication |
| 125644061 | 12564406 | 5 | Premedication |
| 125644061 | 12564406 | 6 | Arthritis |
| 125644061 | 12564406 | 7 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125644061 | 12564406 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125644061 | 12564406 | Cough | |
| 125644061 | 12564406 | Diarrhoea | |
| 125644061 | 12564406 | Ear pruritus | |
| 125644061 | 12564406 | Gastrointestinal inflammation | |
| 125644061 | 12564406 | Hypersensitivity | |
| 125644061 | 12564406 | Infection | |
| 125644061 | 12564406 | Laceration | |
| 125644061 | 12564406 | Laryngeal oedema | |
| 125644061 | 12564406 | Mucosal infection | |
| 125644061 | 12564406 | Mucosal inflammation | |
| 125644061 | 12564406 | Pain | |
| 125644061 | 12564406 | Pruritus generalised | |
| 125644061 | 12564406 | Rhinitis | |
| 125644061 | 12564406 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 125644061 | 12564406 | 1 | 20160205 | 20160205 | 0 | |
| 125644061 | 12564406 | 2 | 2015 | 0 | ||
| 125644061 | 12564406 | 3 | 20150516 | 0 |