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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1048002415 | 10480024 | 15 | F | 2013 | 20160908 | 20140929 | 20160909 | EXP | CA-ROCHE-1332993 | ROCHE | 70.25 | YR | F | Y | 102.10000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1048002415 | 10480024 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST RITUXIMAB RECEIVED: 31/JUL/2013.?MOST RECENT DOSE ON 05/FEB/2014?LAST DOSE 07/JUL/2015. | N | H06453,H06553 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||
| 1048002415 | 10480024 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | TREATMENT DETAILS AS PRE TREATING PHYSICIAN | N | H06453,H06553 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||
| 1048002415 | 10480024 | 3 | SS | RITUXAN | RITUXIMAB | 1 | N | H06453,H06553 | 103705 | ||||||||||
| 1048002415 | 10480024 | 4 | SS | RITUXAN | RITUXIMAB | 1 | N | H06453,H06553 | 103705 | ||||||||||
| 1048002415 | 10480024 | 5 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | 50722 | 1000 | MG | ||||||||
| 1048002415 | 10480024 | 6 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 500 | MG | BID | |||||||
| 1048002415 | 10480024 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | 9 | MG | QD | |||||||
| 1048002415 | 10480024 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | TREATMENT DETAILS AS PER TREATING PHYSICIAN | U | 0 | 10 | MG | QD | ||||||
| 1048002415 | 10480024 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 1048002415 | 10480024 | 10 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 0 | 3000 | MG | |||||||||
| 1048002415 | 10480024 | 11 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 0 | 1.5 | G | QOD | ||||||||
| 1048002415 | 10480024 | 12 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 1048002415 | 10480024 | 13 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | BID | ||||||||
| 1048002415 | 10480024 | 14 | C | MELOXICAM. | MELOXICAM | 1 | Unknown | 0 | 15 | MG | |||||||||
| 1048002415 | 10480024 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | BID | ||||||||||
| 1048002415 | 10480024 | 16 | C | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Unknown | 0 | 100 | MG | |||||||||
| 1048002415 | 10480024 | 17 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | 1000 | UG | |||||||||
| 1048002415 | 10480024 | 18 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Unknown | 0 | 100 | MG | QD | ||||||||
| 1048002415 | 10480024 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | .125 | MG | |||||||||
| 1048002415 | 10480024 | 20 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Unknown | 0 | BID | ||||||||||
| 1048002415 | 10480024 | 21 | C | DOMPERIDONE | DOMPERIDONE | 1 | Unknown | 0 | 20 | MG | |||||||||
| 1048002415 | 10480024 | 22 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 1048002415 | 10480024 | 23 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | 1 | MG | |||||||||
| 1048002415 | 10480024 | 24 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 20 | MG | BID | ||||||||
| 1048002415 | 10480024 | 25 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | 500 | MG | BID | ||||||||
| 1048002415 | 10480024 | 26 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 1048002415 | 10480024 | 27 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 0 | 400 | MG | QD | ||||||||
| 1048002415 | 10480024 | 28 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1048002415 | 10480024 | 1 | Rheumatoid arthritis |
| 1048002415 | 10480024 | 2 | Polymyositis |
| 1048002415 | 10480024 | 3 | Systemic lupus erythematosus |
| 1048002415 | 10480024 | 4 | Mixed connective tissue disease |
| 1048002415 | 10480024 | 5 | Rheumatoid arthritis |
| 1048002415 | 10480024 | 6 | Myositis |
| 1048002415 | 10480024 | 7 | Rheumatoid arthritis |
| 1048002415 | 10480024 | 8 | Myositis |
| 1048002415 | 10480024 | 9 | Vasculitis |
| 1048002415 | 10480024 | 10 | Rheumatoid arthritis |
| 1048002415 | 10480024 | 12 | Premedication |
| 1048002415 | 10480024 | 22 | Premedication |
| 1048002415 | 10480024 | 26 | Rheumatoid arthritis |
| 1048002415 | 10480024 | 28 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1048002415 | 10480024 | HO |
| 1048002415 | 10480024 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1048002415 | 10480024 | Abdominal pain | |
| 1048002415 | 10480024 | Abdominal pain upper | |
| 1048002415 | 10480024 | Aortic valve stenosis | |
| 1048002415 | 10480024 | Arthralgia | |
| 1048002415 | 10480024 | Asthma | |
| 1048002415 | 10480024 | Blood pressure diastolic abnormal | |
| 1048002415 | 10480024 | Blood pressure fluctuation | |
| 1048002415 | 10480024 | Campylobacter gastroenteritis | |
| 1048002415 | 10480024 | Carpal tunnel syndrome | |
| 1048002415 | 10480024 | Chest pain | |
| 1048002415 | 10480024 | Cough | |
| 1048002415 | 10480024 | Drug ineffective | |
| 1048002415 | 10480024 | Dupuytren's contracture | |
| 1048002415 | 10480024 | Food poisoning | |
| 1048002415 | 10480024 | Helicobacter infection | |
| 1048002415 | 10480024 | Hyperhidrosis | |
| 1048002415 | 10480024 | Hypoaesthesia | |
| 1048002415 | 10480024 | Immunosuppression | |
| 1048002415 | 10480024 | Infusion related reaction | |
| 1048002415 | 10480024 | Joint swelling | |
| 1048002415 | 10480024 | Nasopharyngitis | |
| 1048002415 | 10480024 | Nausea | |
| 1048002415 | 10480024 | Off label use | |
| 1048002415 | 10480024 | Stoma site erythema | |
| 1048002415 | 10480024 | Systemic lupus erythematosus rash | |
| 1048002415 | 10480024 | Tooth injury | |
| 1048002415 | 10480024 | Vertigo | |
| 1048002415 | 10480024 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 1048002415 | 10480024 | 1 | 20130717 | 0 | ||
| 1048002415 | 10480024 | 2 | 20140122 | 0 | ||
| 1048002415 | 10480024 | 6 | 2012 | 0 | ||
| 1048002415 | 10480024 | 8 | 2001 | 0 | ||
| 1048002415 | 10480024 | 11 | 2012 | 0 | ||
| 1048002415 | 10480024 | 12 | 20130717 | 0 | ||
| 1048002415 | 10480024 | 22 | 20130717 | 0 | ||
| 1048002415 | 10480024 | 27 | 2001 | 0 | ||
| 1048002415 | 10480024 | 28 | 20130717 | 0 |