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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121893745 | 12189374 | 5 | F | 20140723 | 20160919 | 20160317 | 20160922 | PER | PHHY2014US136019 | NOVARTIS | 57.78 | YR | F | Y | 0.00000 | 20160923 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121893745 | 12189374 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | QD | 22527 | CAPSULE | QD | ||||||||
| 121893745 | 12189374 | 2 | C | FLUVACCIN | INFLUENZA VIRUS VACCINE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 121893745 | 12189374 | 3 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 4 UNK, Q8H PRN | Y | 0 | Q8H | ||||||||
| 121893745 | 12189374 | 4 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Y | 0 | |||||||||||
| 121893745 | 12189374 | 5 | C | LACTATED RINGERS | CALCIUM CHLORIDEPOTASSIUM CHLORIDESODIUM CHLORIDESODIUM LACTATE | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121893745 | 12189374 | 1 | Multiple sclerosis |
| 121893745 | 12189374 | 2 | Antiviral prophylaxis |
| 121893745 | 12189374 | 3 | Nausea |
| 121893745 | 12189374 | 4 | Vomiting |
| 121893745 | 12189374 | 5 | Electrolyte substitution therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121893745 | 12189374 | Alopecia | |
| 121893745 | 12189374 | Constipation | |
| 121893745 | 12189374 | Diplopia | |
| 121893745 | 12189374 | Fatigue | |
| 121893745 | 12189374 | Feeling abnormal | |
| 121893745 | 12189374 | Haemangioma of skin | |
| 121893745 | 12189374 | Halo vision | |
| 121893745 | 12189374 | Headache | |
| 121893745 | 12189374 | Insomnia | |
| 121893745 | 12189374 | Lentigo | |
| 121893745 | 12189374 | Limb discomfort | |
| 121893745 | 12189374 | Melanocytic naevus | |
| 121893745 | 12189374 | Muscular weakness | |
| 121893745 | 12189374 | Seborrhoeic keratosis |
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 |
|---|---|---|---|---|---|---|
| 121893745 | 12189374 | 2 | 20140916 | 20140916 | 0 | |
| 121893745 | 12189374 | 3 | 20151120 | 20151123 | 0 | |
| 121893745 | 12189374 | 5 | 20151028 | 20151028 | 0 |