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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124777594 | 12477759 | 4 | F | 201601 | 20160822 | 20160617 | 20160906 | PER | US-BAYER-2016-111590 | BAYER | 68.00 | YR | E | F | Y | 68.50000 | KG | 20160906 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124777594 | 12477759 | 1 | PS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 8 MIU, QOD | Y | 103471 | 8 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 124777594 | 12477759 | 2 | SS | BETACONNECT | DEVICE | 1 | 0 | ||||||||||||
| 124777594 | 12477759 | 3 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | BID | |||||||
| 124777594 | 12477759 | 4 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 124777594 | 12477759 | 5 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 10 MG, HS | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124777594 | 12477759 | 1 | Multiple sclerosis |
| 124777594 | 12477759 | 2 | Device therapy |
| 124777594 | 12477759 | 3 | Gait disturbance |
| 124777594 | 12477759 | 4 | Gait disturbance |
| 124777594 | 12477759 | 5 | Gait disturbance |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124777594 | 12477759 | Circumstance or information capable of leading to device use error | |
| 124777594 | 12477759 | Device difficult to use | |
| 124777594 | 12477759 | Device intolerance | |
| 124777594 | 12477759 | Dizziness | |
| 124777594 | 12477759 | Injection site haematoma | |
| 124777594 | 12477759 | Injection site pain |
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 |
|---|---|---|---|---|---|---|
| 124777594 | 12477759 | 1 | 20160101 | 20160401 | 0 | |
| 124777594 | 12477759 | 3 | 2012 | 0 | ||
| 124777594 | 12477759 | 5 | 201605 | 2016 | 0 |