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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 980504211 | 9805042 | 11 | F | 20121126 | 20160808 | 20140109 | 20160810 | EXP | CA-ROCHE-1161404 | ROCHE | 44.47 | YR | F | Y | 113.50000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 980504211 | 9805042 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE ON 11/JUL/2013, 22/JUN/2014, 28/JUL/2014 AND 08/MAR/2016. | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 980504211 | 9805042 | 2 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 100 | MG | ||||||||
| 980504211 | 9805042 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 980504211 | 9805042 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 980504211 | 9805042 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 980504211 | 9805042 | 6 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 | ||||||||||||
| 980504211 | 9805042 | 7 | C | ACETAMINOFEN | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 980504211 | 9805042 | 8 | C | ACETAMINOFEN | ACETAMINOPHEN | 1 | Oral | 0 | 1000 | MG | |||||||||
| 980504211 | 9805042 | 9 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 980504211 | 9805042 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 980504211 | 9805042 | 11 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 980504211 | 9805042 | 1 | Rheumatoid arthritis |
| 980504211 | 9805042 | 2 | Premedication |
| 980504211 | 9805042 | 3 | Premedication |
| 980504211 | 9805042 | 5 | Alopecia |
| 980504211 | 9805042 | 9 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 980504211 | 9805042 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 980504211 | 9805042 | Arthralgia | |
| 980504211 | 9805042 | Dyspnoea | |
| 980504211 | 9805042 | Flushing | |
| 980504211 | 9805042 | Influenza | |
| 980504211 | 9805042 | Infusion related reaction | |
| 980504211 | 9805042 | Nasal congestion | |
| 980504211 | 9805042 | Nasopharyngitis | |
| 980504211 | 9805042 | Ovarian cyst | |
| 980504211 | 9805042 | Rheumatoid arthritis | |
| 980504211 | 9805042 | Throat irritation | |
| 980504211 | 9805042 | Vaginitis bacterial | |
| 980504211 | 9805042 | Weight decreased | |
| 980504211 | 9805042 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 980504211 | 9805042 | 1 | 20091208 | 0 | ||
| 980504211 | 9805042 | 2 | 20091208 | 0 | ||
| 980504211 | 9805042 | 3 | 20091208 | 20110829 | 0 | |
| 980504211 | 9805042 | 4 | 20120509 | 0 | ||
| 980504211 | 9805042 | 7 | 20120509 | 0 | ||
| 980504211 | 9805042 | 8 | 20091208 | 20110829 | 0 | |
| 980504211 | 9805042 | 9 | 20091208 | 0 | ||
| 980504211 | 9805042 | 10 | 20091208 | 0 |