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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124760884 | 12476088 | 4 | F | 2016 | 20160907 | 20160617 | 20160915 | EXP | US-SA-2016SA109442 | AVENTIS | 47.00 | YR | A | F | Y | 0.00000 | 20160915 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124760884 | 12476088 | 1 | PS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | UNKNOWN | 103948 | 12 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 124760884 | 12476088 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 124760884 | 12476088 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124760884 | 12476088 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124760884 | 12476088 | HO |
| 124760884 | 12476088 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124760884 | 12476088 | Asthenia | |
| 124760884 | 12476088 | Dehydration | |
| 124760884 | 12476088 | Depressed level of consciousness | |
| 124760884 | 12476088 | Fatigue | |
| 124760884 | 12476088 | Headache | |
| 124760884 | 12476088 | Liver function test abnormal | |
| 124760884 | 12476088 | Movement disorder | |
| 124760884 | 12476088 | Pain | |
| 124760884 | 12476088 | Paralysis | |
| 124760884 | 12476088 | T-lymphocyte count abnormal | |
| 124760884 | 12476088 | Thyroid function test abnormal | |
| 124760884 | 12476088 | Urinary incontinence | |
| 124760884 | 12476088 | Vomiting | |
| 124760884 | 12476088 | White blood cell count abnormal |
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 |
|---|---|---|---|---|---|---|
| 124760884 | 12476088 | 1 | 20160523 | 20160527 | 0 |