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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121872894 | 12187289 | 4 | F | 20160304 | 20160628 | 20160317 | 20160702 | PER | PHHY2016US035242 | NOVARTIS | 33.91 | YR | F | Y | 104.30000 | KG | 20160702 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121872894 | 12187289 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | QD | U | 22527 | CAPSULE | QD | |||||||
| 121872894 | 12187289 | 2 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous drip | UNK | Y | 0 | |||||||||
| 121872894 | 12187289 | 3 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 1 G, UNK | Y | 0 | 1 | G | |||||||
| 121872894 | 12187289 | 4 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121872894 | 12187289 | 1 | Multiple sclerosis |
| 121872894 | 12187289 | 2 | Multiple sclerosis relapse |
| 121872894 | 12187289 | 4 | Blood cortisol decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121872894 | 12187289 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121872894 | 12187289 | Heart rate decreased | |
| 121872894 | 12187289 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 121872894 | 12187289 | 1 | 20160304 | 0 | ||
| 121872894 | 12187289 | 2 | 20160129 | 20160203 | 0 | |
| 121872894 | 12187289 | 3 | 20160302 | 20160305 | 0 | |
| 121872894 | 12187289 | 4 | 20160302 | 20160316 | 0 |