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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123406254 | 12340625 | 4 | F | 20160729 | 20160506 | 20160802 | PER | PHEH2016US010862 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160802 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123406254 | 12340625 | 1 | PS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 1-2: 0.0625 MG (0.25 ML), QOD | 125290 | .062 | MG | SOLUTION FOR INJECTION | |||||||
| 123406254 | 12340625 | 2 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 3-4: 0.125 MG (0.5 ML), QOD | 125290 | .125 | MG | SOLUTION FOR INJECTION | |||||||
| 123406254 | 12340625 | 3 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 5-6: 0.1875 MG (0.75 ML), QOD | 125290 | .187 | MG | SOLUTION FOR INJECTION | |||||||
| 123406254 | 12340625 | 4 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 7+: 0.25 MG (1 ML), QOD | 125290 | .25 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123406254 | 12340625 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123406254 | 12340625 | Headache | |
| 123406254 | 12340625 | Hepatic enzyme increased | |
| 123406254 | 12340625 | Incorrect route of drug administration | |
| 123406254 | 12340625 | Injection site bruising | |
| 123406254 | 12340625 | Injection site erythema | |
| 123406254 | 12340625 | 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 |
|---|---|---|---|---|---|---|
| 123406254 | 12340625 | 1 | 20160301 | 0 |