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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123110372 | 12311037 | 2 | F | 2015 | 20160808 | 20160427 | 20160816 | EXP | US-BAYER-2015-485630 | BAYER | 68.00 | YR | E | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123110372 | 12311037 | 1 | PS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 8 MIU, QOD | 44145A | 103471 | 8 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 123110372 | 12311037 | 2 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 6 MIU, QOD | 51075A | 103471 | 6 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 123110372 | 12311037 | 3 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 2 MIU, ONCE | 51075A | 103471 | 2 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | 1X | |||||
| 123110372 | 12311037 | 4 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 6 MIU, ONCE | 51075A | 103471 | 6 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | 1X | |||||
| 123110372 | 12311037 | 5 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 6 MIU, QOD | 52095A | 103471 | 6 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 123110372 | 12311037 | 6 | SS | BETASERON | INTERFERON BETA-1B | 1 | Subcutaneous | 6 MIU, QOD | 52198A | 103471 | 6 | MIU | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QOD | |||||
| 123110372 | 12311037 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123110372 | 12311037 | 1 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 2 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 3 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 4 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 5 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 6 | Relapsing-remitting multiple sclerosis |
| 123110372 | 12311037 | 7 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123110372 | 12311037 | HO |
| 123110372 | 12311037 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123110372 | 12311037 | Activities of daily living impaired | |
| 123110372 | 12311037 | Blood sodium decreased | |
| 123110372 | 12311037 | Confusional state | |
| 123110372 | 12311037 | Cystitis | |
| 123110372 | 12311037 | Dizziness | |
| 123110372 | 12311037 | Drug dose omission | |
| 123110372 | 12311037 | Drug intolerance | |
| 123110372 | 12311037 | Ear infection | |
| 123110372 | 12311037 | Erythema | |
| 123110372 | 12311037 | Fall | |
| 123110372 | 12311037 | Fatigue | |
| 123110372 | 12311037 | Haematoma | |
| 123110372 | 12311037 | Influenza like illness | |
| 123110372 | 12311037 | Injury associated with device | |
| 123110372 | 12311037 | Malaise | |
| 123110372 | 12311037 | Nausea | |
| 123110372 | 12311037 | Pain | |
| 123110372 | 12311037 | Peripheral swelling | |
| 123110372 | 12311037 | Prescribed underdose | |
| 123110372 | 12311037 | Product use issue | |
| 123110372 | 12311037 | Pyrexia | |
| 123110372 | 12311037 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 123110372 | 12311037 | 1 | 20150825 | 201512 | 0 | |
| 123110372 | 12311037 | 2 | 201512 | 201602 | 0 | |
| 123110372 | 12311037 | 3 | 20160220 | 20160220 | 0 | |
| 123110372 | 12311037 | 4 | 20160221 | 20160221 | 0 | |
| 123110372 | 12311037 | 5 | 201602 | 0 |