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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123654472 | 12365447 | 2 | F | 20160418 | 20160713 | 20160512 | 20160720 | EXP | AU-BIOGEN-2016BI00234484 | BIOGEN | 38.22 | YR | M | Y | 0.00000 | 20160720 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123654472 | 12365447 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | UNKNOWN | ||||||||
| 123654472 | 12365447 | 2 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 10 | MG | PREPARATION FOR ORAL USE(NOS) | BID | |||||||
| 123654472 | 12365447 | 3 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 0 | 300 | MG | PREPARATION FOR ORAL USE(NOS) | BID | |||||||
| 123654472 | 12365447 | 4 | C | Sodium Valproate | VALPROATE SODIUM | 1 | Oral | 0 | 1 | G | PREPARATION FOR ORAL USE(NOS) | BID | |||||||
| 123654472 | 12365447 | 5 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | PREPARATION FOR ORAL USE(NOS) | QD | |||||||
| 123654472 | 12365447 | 6 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | PREPARATION FOR ORAL USE(NOS) | QD | |||||||
| 123654472 | 12365447 | 7 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 0 | 100 | MG | PREPARATION FOR ORAL USE(NOS) | QD | |||||||
| 123654472 | 12365447 | 8 | C | Cholecalciferol | CHOLECALCIFEROL | 1 | Oral | 0 | PREPARATION FOR ORAL USE(NOS) | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123654472 | 12365447 | 1 | Multiple sclerosis |
| 123654472 | 12365447 | 2 | Muscle spasms |
| 123654472 | 12365447 | 3 | Seizure |
| 123654472 | 12365447 | 4 | Seizure |
| 123654472 | 12365447 | 5 | Gastrooesophageal reflux disease |
| 123654472 | 12365447 | 6 | Anxiety |
| 123654472 | 12365447 | 8 | Routine health maintenance |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123654472 | 12365447 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123654472 | 12365447 | Partial seizures | |
| 123654472 | 12365447 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 123654472 | 12365447 | 1 | 20090917 | 0 | ||
| 123654472 | 12365447 | 2 | 20090101 | 0 | ||
| 123654472 | 12365447 | 3 | 20150831 | 0 | ||
| 123654472 | 12365447 | 4 | 20150414 | 0 | ||
| 123654472 | 12365447 | 5 | 20150112 | 0 | ||
| 123654472 | 12365447 | 6 | 20000101 | 0 | ||
| 123654472 | 12365447 | 7 | 20000101 | 0 | ||
| 123654472 | 12365447 | 8 | 19990101 | 0 |