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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287682 | 12528768 | 2 | F | 20160401 | 20160805 | 20160705 | 20160810 | EXP | CA-BIOGEN-2016BI00251809 | BIOGEN | 52.69 | YR | F | Y | 47.00000 | KG | 20160810 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125287682 | 12528768 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | Y | 11469 | 300 | MCI | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125287682 | 12528768 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | Y | 11469 | 300 | MCI | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125287682 | 12528768 | 3 | SS | FAMPYRA | DALFAMPRIDINE | 1 | Oral | AS DIRECTED | 22250 | PROLONGED-RELEASE TABLET | |||||||||
| 125287682 | 12528768 | 4 | C | LYRICA | PREGABALIN | 1 | Oral | 0 | 50 | MG | UNKNOWN | BID | |||||||
| 125287682 | 12528768 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | 4000 | IU | UNKNOWN | QD | |||||||
| 125287682 | 12528768 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | 1000 | IU | UNKNOWN | QD | |||||||
| 125287682 | 12528768 | 7 | C | Pantoloc | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | UNKNOWN | QD | |||||||
| 125287682 | 12528768 | 8 | C | SLOW-K | POTASSIUM CHLORIDE | 1 | Unknown | 0 | 40 | MEQ | UNKNOWN | QD | |||||||
| 125287682 | 12528768 | 9 | C | SLOW-K | POTASSIUM CHLORIDE | 1 | Oral | AS DIRECTED | 0 | 20 | MEQ | UNKNOWN | QD | ||||||
| 125287682 | 12528768 | 10 | C | Lactobacillus | LACTOBACILLUS ACIDOPHILUS | 1 | Oral | 1 BILLION | 0 | CAPSULE | BID | ||||||||
| 125287682 | 12528768 | 11 | C | Calcium | CALCIUM | 1 | Oral | 1-4 TABLETS IN AM | 0 | 200 | MG | CHEWABLE TABLET | QD | ||||||
| 125287682 | 12528768 | 12 | C | Calcium | CALCIUM | 1 | Oral | 1-4 TABLETS | 0 | 200 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 13 | C | LACTULOSE. | LACTULOSE | 1 | Oral | 15-30 ML PRN | 0 | UNKNOWN | QD | ||||||||
| 125287682 | 12528768 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Oral | IN AM | 0 | 50 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 15 | C | PREDNISONE. | PREDNISONE | 1 | Oral | IN AM | 0 | 30 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 16 | C | PREDNISONE. | PREDNISONE | 1 | Oral | IN AM | 0 | 30 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Oral | IN AM | 0 | 20 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Oral | IN AM | 0 | 10 | MG | TABLETS | QD | ||||||
| 125287682 | 12528768 | 19 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 1-2 TABS Q4-Q6 PRN | 0 | 325 | MG | TABLETS | |||||||
| 125287682 | 12528768 | 20 | C | NOROXIN | NORFLOXACIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125287682 | 12528768 | 21 | C | MEROPENEM. | MEROPENEM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125287682 | 12528768 | 1 | Relapsing-remitting multiple sclerosis |
| 125287682 | 12528768 | 3 | Product used for unknown indication |
| 125287682 | 12528768 | 4 | Product used for unknown indication |
| 125287682 | 12528768 | 5 | Product used for unknown indication |
| 125287682 | 12528768 | 7 | Product used for unknown indication |
| 125287682 | 12528768 | 8 | Product used for unknown indication |
| 125287682 | 12528768 | 10 | Product used for unknown indication |
| 125287682 | 12528768 | 11 | Product used for unknown indication |
| 125287682 | 12528768 | 13 | Product used for unknown indication |
| 125287682 | 12528768 | 14 | Product used for unknown indication |
| 125287682 | 12528768 | 19 | Product used for unknown indication |
| 125287682 | 12528768 | 20 | Product used for unknown indication |
| 125287682 | 12528768 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125287682 | 12528768 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125287682 | 12528768 | Escherichia urinary tract infection | |
| 125287682 | 12528768 | Hypoaesthesia | |
| 125287682 | 12528768 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 125287682 | 12528768 | 1 | 20080714 | 201604 | 0 | |
| 125287682 | 12528768 | 14 | 20160409 | 20160415 | 0 | |
| 125287682 | 12528768 | 15 | 20160418 | 20160419 | 0 | |
| 125287682 | 12528768 | 16 | 20160409 | 20160415 | 0 | |
| 125287682 | 12528768 | 17 | 20160420 | 20160421 | 0 | |
| 125287682 | 12528768 | 18 | 20160422 | 20160423 | 0 |