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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121825475 | 12182547 | 5 | F | 201602 | 20160913 | 20160316 | 20160919 | PER | PHEH2016US006200 | NOVARTIS | 51.86 | YR | F | Y | 91.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121825475 | 12182547 | 1 | PS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | 0.25 ML, QOD (WEEK 1-2 , 0.0625 MG) | 125290 | .25 | ML | SOLUTION FOR INJECTION | |||||||
| 121825475 | 12182547 | 2 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | 0.5 ML, QOD (WEEK 3-4 , 0.125 MG) | 125290 | .5 | ML | SOLUTION FOR INJECTION | |||||||
| 121825475 | 12182547 | 3 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | 0.75 ML, QOD (WEEK 5-6 , 0.1875 MG) | 125290 | .75 | ML | SOLUTION FOR INJECTION | |||||||
| 121825475 | 12182547 | 4 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | 1 ML, QOD (WEEKS 7+, 0.25 MG) | 54223-1A | 125290 | 1 | ML | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121825475 | 12182547 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121825475 | 12182547 | Abdominal distension | |
| 121825475 | 12182547 | Confusional state | |
| 121825475 | 12182547 | Drug ineffective | |
| 121825475 | 12182547 | Gait disturbance | |
| 121825475 | 12182547 | Injection site mass | |
| 121825475 | 12182547 | Injection site pain | |
| 121825475 | 12182547 | Muscle spasms | |
| 121825475 | 12182547 | Muscle twitching | |
| 121825475 | 12182547 | Musculoskeletal pain | |
| 121825475 | 12182547 | Pain in extremity | |
| 121825475 | 12182547 | Paraesthesia | |
| 121825475 | 12182547 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 121825475 | 12182547 | 1 | 20160218 | 0 |