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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116633535 | 11663353 | 5 | F | 20160923 | 20151027 | 20160928 | EXP | BR-ROCHE-1591139 | ROCHE | 0.00 | F | Y | 98.50000 | KG | 20160928 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116633535 | 11663353 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | ON 30/DEC/2014, 01/MAR/2016RECEIVED THE LAST DOSE FOR RITUXIMAB | U | 103705 | SOLUTION FOR INFUSION | ||||||||
| 116633535 | 11663353 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 1 TABLET IN MORNING 1 TABLET AT NIGHT | U | 0 | 5 | MG | TABLET | BID | |||||
| 116633535 | 11663353 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | 500 | MG | |||||||||
| 116633535 | 11663353 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | 300 | MG | |||||||||
| 116633535 | 11663353 | 5 | C | LISADOR | DIPYRONEPROMETHAZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116633535 | 11663353 | 6 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | IN THE MORNING | 0 | 50 | MG | QD | |||||||
| 116633535 | 11663353 | 7 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | IN THE MORNING | 0 | 50 | MG | QD | |||||||
| 116633535 | 11663353 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 1 TABLET ON TUESDAY AND 1 TABLET ON THURSDAY | 0 | 5 | MG | TABLET | |||||||
| 116633535 | 11663353 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 30 MINUTES AFTER ALL THE DRUGS IN THE MORNING, 1 TABLET IN THE MORNING AND 1 TABLET AT NIGHT | 0 | 20 | MG | TABLET | |||||||
| 116633535 | 11663353 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 3 TABLETS IN THE MORNING AND AT NIGHT ON WEDNESDAY | 0 | 2.5 | MG | TABLET | |||||||
| 116633535 | 11663353 | 11 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 2 TABLETS AT NIGHT FOR DEPRESSION AND AS A SLEEP | 0 | 25 | MG | BID | |||||||
| 116633535 | 11663353 | 12 | C | HYDROFLUX | 2 | 0 | |||||||||||||
| 116633535 | 11663353 | 13 | C | ACECLOFENAC | ACECLOFENAC | 1 | Unknown | AT NIGHT | 0 | 100 | MG | QD | |||||||
| 116633535 | 11663353 | 14 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | Unknown | AT NIGHT?EZETIMIBE 10 MG/ SIMVASTATIN 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 116633535 | 11663353 | 15 | C | CEBRALAT | CILOSTAZOL | 1 | Unknown | 1 TABLET IN THE MORNING AND 1 TABLET AT NIGHT | 0 | 50 | MG | TABLET | |||||||
| 116633535 | 11663353 | 16 | C | HIDROMED | HYDROCHLOROTHIAZIDE | 1 | Unknown | 0 | 25 | MG | TABLET | QD | |||||||
| 116633535 | 11663353 | 17 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 1 TABLET IN MORNING AND AT NIGHT | 0 | 5 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116633535 | 11663353 | 1 | Rheumatoid arthritis |
| 116633535 | 11663353 | 2 | Rheumatoid arthritis |
| 116633535 | 11663353 | 3 | Pain |
| 116633535 | 11663353 | 4 | Pain |
| 116633535 | 11663353 | 6 | Hypertension |
| 116633535 | 11663353 | 7 | Hypertension |
| 116633535 | 11663353 | 8 | Rheumatoid arthritis |
| 116633535 | 11663353 | 11 | Depression |
| 116633535 | 11663353 | 14 | Blood cholesterol increased |
| 116633535 | 11663353 | 17 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116633535 | 11663353 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116633535 | 11663353 | Foot deformity | |
| 116633535 | 11663353 | Mobility decreased | |
| 116633535 | 11663353 | Pain | |
| 116633535 | 11663353 | Pyrexia | |
| 116633535 | 11663353 | Rash erythematous | |
| 116633535 | 11663353 | Rheumatoid arthritis | |
| 116633535 | 11663353 | Skin ulcer |
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 |
|---|---|---|---|---|---|---|
| 116633535 | 11663353 | 1 | 20141211 | 0 |