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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121389017 | 12138901 | 7 | F | 201601 | 20160830 | 20160302 | 20160913 | EXP | DE-BIOGEN-2016BI00191460 | BIOGEN | 49.38 | YR | F | Y | 0.00000 | 20160913 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121389017 | 12138901 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | N | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 121389017 | 12138901 | 2 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | 300 | MG | UNKNOWN | ||||||||
| 121389017 | 12138901 | 3 | C | pantoprazol | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121389017 | 12138901 | 4 | C | thyronajod | LEVOTHYROXINE SODIUMPOTASSIUM IODIDE | 1 | Unknown | 0 | 75 | MG | UNKNOWN | ||||||||
| 121389017 | 12138901 | 5 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121389017 | 12138901 | 6 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121389017 | 12138901 | 7 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121389017 | 12138901 | 8 | C | dapagliflozin | DAPAGLIFLOZIN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121389017 | 12138901 | 1 | Multiple sclerosis |
| 121389017 | 12138901 | 2 | Product used for unknown indication |
| 121389017 | 12138901 | 3 | Product used for unknown indication |
| 121389017 | 12138901 | 4 | Hypothyroidism |
| 121389017 | 12138901 | 5 | Hypertension |
| 121389017 | 12138901 | 6 | Diabetes mellitus |
| 121389017 | 12138901 | 7 | Diabetes mellitus |
| 121389017 | 12138901 | 8 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121389017 | 12138901 | OT |
| 121389017 | 12138901 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121389017 | 12138901 | Alanine aminotransferase increased | |
| 121389017 | 12138901 | Anaemia | |
| 121389017 | 12138901 | Aspartate aminotransferase increased | |
| 121389017 | 12138901 | Immune reconstitution inflammatory syndrome | |
| 121389017 | 12138901 | Pneumonia aspiration | |
| 121389017 | 12138901 | Progressive multifocal leukoencephalopathy | |
| 121389017 | 12138901 | Respiratory moniliasis | |
| 121389017 | 12138901 | Sepsis | |
| 121389017 | 12138901 | Staphylococcal infection | |
| 121389017 | 12138901 | Toxoplasmosis |
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 |
|---|---|---|---|---|---|---|
| 121389017 | 12138901 | 1 | 201501 | 20160104 | 0 |