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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126119393 | 12611939 | 3 | F | 20160527 | 20160816 | 20160801 | 20160825 | EXP | US-BAYER-2016-114917 | BAYER | 56.00 | YR | A | F | Y | 0.00000 | 20160825 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126119393 | 12611939 | 1 | PS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 8 UNK, UNK | 52097A | 103471 | 8 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 126119393 | 12611939 | 2 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 2 MIU, QOD | 52035A | 103471 | 2 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 126119393 | 12611939 | 3 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 6 MIU, QOD | 52097A | 103471 | 6 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 126119393 | 12611939 | 4 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 0.25 MG, QOD | 103471 | .25 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | ||||||
| 126119393 | 12611939 | 5 | SS | BETACONNECT | DEVICE | 1 | UNK | 0 | |||||||||||
| 126119393 | 12611939 | 6 | C | ESOMEPRAZOLE W/NAPROXEN | ESOMEPRAZOLE MAGNESIUMNAPROXEN | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 126119393 | 12611939 | 7 | C | NAPROXEN. | NAPROXEN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126119393 | 12611939 | 1 | Relapsing-remitting multiple sclerosis |
| 126119393 | 12611939 | 2 | Multiple sclerosis |
| 126119393 | 12611939 | 3 | Relapsing-remitting multiple sclerosis |
| 126119393 | 12611939 | 4 | Relapsing-remitting multiple sclerosis |
| 126119393 | 12611939 | 5 | Device therapy |
| 126119393 | 12611939 | 6 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126119393 | 12611939 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126119393 | 12611939 | Feeling hot | |
| 126119393 | 12611939 | Headache | |
| 126119393 | 12611939 | Hepatic enzyme increased | |
| 126119393 | 12611939 | Hepatic steatosis | |
| 126119393 | 12611939 | Injection site bruising | |
| 126119393 | 12611939 | Injection site haemorrhage | |
| 126119393 | 12611939 | Injection site pruritus | |
| 126119393 | 12611939 | Injection site reaction | |
| 126119393 | 12611939 | Injection site warmth | |
| 126119393 | 12611939 | Pain | |
| 126119393 | 12611939 | Pruritus | |
| 126119393 | 12611939 | Pruritus generalised | |
| 126119393 | 12611939 | 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 |
|---|---|---|---|---|---|---|
| 126119393 | 12611939 | 1 | 20160526 | 0 | ||
| 126119393 | 12611939 | 2 | 20160527 | 0 | ||
| 126119393 | 12611939 | 6 | 201605 | 0 |