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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125078783 | 12507878 | 3 | F | 201608 | 20160816 | 20160629 | 20160823 | EXP | PHEH2016US016093 | NOVARTIS | 30.06 | YR | F | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125078783 | 12507878 | 1 | PS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 1-2: 0.0625 MG (0.25 ML), QOD | 54223-1A | 125290 | .25 | ML | SOLUTION FOR INJECTION | ||||||
| 125078783 | 12507878 | 2 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEK 3-4: 0.125 MG (0.5 ML), QOD | 125290 | .5 | ML | SOLUTION FOR INJECTION | |||||||
| 125078783 | 12507878 | 3 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 5-6: 0.1875 MG (0.75 ML), QOD | 125290 | .75 | ML | SOLUTION FOR INJECTION | |||||||
| 125078783 | 12507878 | 4 | SS | EXTAVIA | INTERFERON BETA-1B | 1 | Subcutaneous | WEEKS 7+: 0.25 MG (1 ML), QOD | 125290 | 1 | ML | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125078783 | 12507878 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125078783 | 12507878 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125078783 | 12507878 | Agitation | |
| 125078783 | 12507878 | Asthenia | |
| 125078783 | 12507878 | Fatigue | |
| 125078783 | 12507878 | Feeling abnormal | |
| 125078783 | 12507878 | Headache | |
| 125078783 | 12507878 | Injection site bruising | |
| 125078783 | 12507878 | Injection site haemorrhage | |
| 125078783 | 12507878 | Injection site pain | |
| 125078783 | 12507878 | Injection site pruritus | |
| 125078783 | 12507878 | Injection site urticaria | |
| 125078783 | 12507878 | Mood altered | |
| 125078783 | 12507878 | Muscular weakness | |
| 125078783 | 12507878 | Neck mass | |
| 125078783 | 12507878 | Product reconstitution issue | |
| 125078783 | 12507878 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 125078783 | 12507878 | 1 | 20160414 | 0 |