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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118396814 | 11839681 | 4 | F | 20150807 | 20160719 | 20151216 | 20160726 | PER | PHHY2015US159991 | NOVARTIS | 38.03 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118396814 | 11839681 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | QD | 22527 | CAPSULE | QD | ||||||||
| 118396814 | 11839681 | 2 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118396814 | 11839681 | 1 | Multiple sclerosis |
| 118396814 | 11839681 | 2 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118396814 | 11839681 | Abdominal discomfort | |
| 118396814 | 11839681 | Anxiety | |
| 118396814 | 11839681 | Dry skin | |
| 118396814 | 11839681 | Dyspnoea | |
| 118396814 | 11839681 | Eczema | |
| 118396814 | 11839681 | Electrocardiogram abnormal | |
| 118396814 | 11839681 | Fatigue | |
| 118396814 | 11839681 | Hand-foot-and-mouth disease | |
| 118396814 | 11839681 | Hemiparesis | |
| 118396814 | 11839681 | Herpes simplex | |
| 118396814 | 11839681 | Oropharyngeal pain | |
| 118396814 | 11839681 | Photosensitivity reaction | |
| 118396814 | 11839681 | Pollakiuria | |
| 118396814 | 11839681 | Rectal discharge | |
| 118396814 | 11839681 | Skin exfoliation | |
| 118396814 | 11839681 | Skin fissures |
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 |
|---|---|---|---|---|---|---|
| 118396814 | 11839681 | 2 | 20151201 | 0 |