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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112792484 | 11279248 | 4 | F | 201506 | 20160914 | 20150717 | 20160920 | EXP | PHHY2015BR077027 | NOVARTIS | 31.91 | YR | F | Y | 52.00000 | KG | 20160920 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112792484 | 11279248 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 112792484 | 11279248 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD (FOR 15 DAYS) | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 112792484 | 11279248 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD (FOR 15 DAYS) | Y | 22527 | .5 | MG | CAPSULE | ||||||
| 112792484 | 11279248 | 4 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112792484 | 11279248 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112792484 | 11279248 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112792484 | 11279248 | Asthma | |
| 112792484 | 11279248 | Bronchospasm | |
| 112792484 | 11279248 | Chest discomfort | |
| 112792484 | 11279248 | Choking | |
| 112792484 | 11279248 | Cough | |
| 112792484 | 11279248 | Decreased immune responsiveness | |
| 112792484 | 11279248 | Drug intolerance | |
| 112792484 | 11279248 | Dyspnoea | |
| 112792484 | 11279248 | Erythema | |
| 112792484 | 11279248 | Flushing | |
| 112792484 | 11279248 | Fungal infection | |
| 112792484 | 11279248 | Herpes virus infection | |
| 112792484 | 11279248 | Hypotension | |
| 112792484 | 11279248 | Klebsiella infection | |
| 112792484 | 11279248 | Leukopenia | |
| 112792484 | 11279248 | Lymphopenia | |
| 112792484 | 11279248 | Malaise | |
| 112792484 | 11279248 | Nasal congestion | |
| 112792484 | 11279248 | Oropharyngeal pain | |
| 112792484 | 11279248 | Pneumonia | |
| 112792484 | 11279248 | Prescribed underdose | |
| 112792484 | 11279248 | Respiratory tract infection | |
| 112792484 | 11279248 | Secretion discharge | |
| 112792484 | 11279248 | Sneezing | |
| 112792484 | 11279248 | Upper airway obstruction | |
| 112792484 | 11279248 | Urinary tract infection | |
| 112792484 | 11279248 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 112792484 | 11279248 | 1 | 20140715 | 201506 | 0 | |
| 112792484 | 11279248 | 2 | 20150702 | 0 | ||
| 112792484 | 11279248 | 3 | 201508 | 0 | ||
| 112792484 | 11279248 | 4 | 201602 | 0 |