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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123309713 | 12330971 | 3 | F | 201604 | 20160901 | 20160504 | 20160914 | PER | US-BAYER-2016-085502 | BAYER | 52.00 | YR | A | F | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123309713 | 12330971 | 1 | PS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 8 MIU, QOD | 51075A | 103471 | 8 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 123309713 | 12330971 | 2 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | UNK | 52035A | 103471 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 123309713 | 12330971 | 3 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 0.25 MG, QD | 5097A | 103471 | .25 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123309713 | 12330971 | 1 | Multiple sclerosis |
| 123309713 | 12330971 | 2 | Multiple sclerosis |
| 123309713 | 12330971 | 3 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123309713 | 12330971 | Drug dose omission | |
| 123309713 | 12330971 | Injection site erythema | |
| 123309713 | 12330971 | Injection site induration | |
| 123309713 | 12330971 | Injection site pain | |
| 123309713 | 12330971 | Injection site reaction | |
| 123309713 | 12330971 | Injection site swelling |
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 |
|---|---|---|---|---|---|---|
| 123309713 | 12330971 | 1 | 20010927 | 0 | ||
| 123309713 | 12330971 | 2 | 20071002 | 0 |