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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118128506 | 11812850 | 6 | F | 20140604 | 20160826 | 20151209 | 20160829 | EXP | CA-ROCHE-1377756 | ROCHE | 62.73 | YR | F | Y | 83.60000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118128506 | 11812850 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 750 | MG | SOLUTION FOR INFUSION | /wk | |||||||
| 118128506 | 11812850 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE OF RITUXIMAB: 04/JUN/2014 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 118128506 | 11812850 | 3 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 500 | MG | SOLUTION FOR INFUSION | ||||||||
| 118128506 | 11812850 | 4 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 500 | MG | SOLUTION FOR INFUSION | ||||||||
| 118128506 | 11812850 | 5 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||||
| 118128506 | 11812850 | 6 | SS | ORACORT | TRIAMCINOLONE ACETONIDE | 1 | Unknown | U | 0 | ||||||||||
| 118128506 | 11812850 | 7 | SS | ORACORT | TRIAMCINOLONE ACETONIDE | 1 | Unknown | U | 0 | ||||||||||
| 118128506 | 11812850 | 8 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 118128506 | 11812850 | 9 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 10 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 118128506 | 11812850 | 11 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 118128506 | 11812850 | 12 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 118128506 | 11812850 | 13 | C | PREMARIN | ESTROGENS, CONJUGATED | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 14 | C | RABEPRAZOLE | RABEPRAZOLE | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 15 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 16 | C | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 17 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 18 | C | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 19 | C | VITAMIN K | PHYTONADIONE | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 20 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 21 | C | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 118128506 | 11812850 | 22 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118128506 | 11812850 | 1 | Granulomatosis with polyangiitis |
| 118128506 | 11812850 | 6 | Product used for unknown indication |
| 118128506 | 11812850 | 8 | Premedication |
| 118128506 | 11812850 | 9 | Premedication |
| 118128506 | 11812850 | 10 | Product used for unknown indication |
| 118128506 | 11812850 | 11 | Premedication |
| 118128506 | 11812850 | 12 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118128506 | 11812850 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118128506 | 11812850 | Blood pressure fluctuation | |
| 118128506 | 11812850 | Blood pressure increased | |
| 118128506 | 11812850 | Cataract | |
| 118128506 | 11812850 | Drug ineffective | |
| 118128506 | 11812850 | Epistaxis | |
| 118128506 | 11812850 | Granulomatosis with polyangiitis | |
| 118128506 | 11812850 | Haemoptysis | |
| 118128506 | 11812850 | Heart rate decreased | |
| 118128506 | 11812850 | Infusion related reaction | |
| 118128506 | 11812850 | Injection site extravasation | |
| 118128506 | 11812850 | Injection site pain | |
| 118128506 | 11812850 | Sinusitis | |
| 118128506 | 11812850 | Somnolence | |
| 118128506 | 11812850 | Spinal disorder | |
| 118128506 | 11812850 | Weight decreased | |
| 118128506 | 11812850 | Weight increased | |
| 118128506 | 11812850 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 118128506 | 11812850 | 1 | 20121122 | 0 | ||
| 118128506 | 11812850 | 2 | 20130604 | 0 | ||
| 118128506 | 11812850 | 3 | 20140917 | 0 | ||
| 118128506 | 11812850 | 4 | 20141204 | 0 | ||
| 118128506 | 11812850 | 5 | 20150601 | 0 | ||
| 118128506 | 11812850 | 8 | 20121122 | 0 | ||
| 118128506 | 11812850 | 11 | 20121122 | 0 | ||
| 118128506 | 11812850 | 12 | 20121122 | 0 | ||
| 118128506 | 11812850 | 22 | 20130601 | 0 |