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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113186334 | 11318633 | 4 | F | 20120802 | 20160816 | 20150729 | 20160819 | PER | PHHY2013US099699 | NOVARTIS | 56.67 | YR | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113186334 | 11318633 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK, QD | 22527 | CAPSULE | QD | ||||||||
| 113186334 | 11318633 | 2 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113186334 | 11318633 | 3 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 113186334 | 11318633 | 4 | C | FENTANYL. | FENTANYL | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113186334 | 11318633 | 5 | C | VERSED | MIDAZOLAM HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 113186334 | 11318633 | 6 | C | PROTINEX | 2 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113186334 | 11318633 | 1 | Multiple sclerosis |
| 113186334 | 11318633 | 2 | Back pain |
| 113186334 | 11318633 | 3 | Pain |
| 113186334 | 11318633 | 4 | Oesophagogastroduodenoscopy |
| 113186334 | 11318633 | 5 | Oesophagogastroduodenoscopy |
| 113186334 | 11318633 | 6 | Ulcer |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113186334 | 11318633 | Bradycardia | |
| 113186334 | 11318633 | Lymphocyte count decreased | |
| 113186334 | 11318633 | 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 |
|---|---|---|---|---|---|---|
| 113186334 | 11318633 | 2 | 20130830 | 0 | ||
| 113186334 | 11318633 | 4 | 20130420 | 20130420 | 0 | |
| 113186334 | 11318633 | 5 | 20130420 | 20130420 | 0 | |
| 113186334 | 11318633 | 6 | 20130420 | 20130506 | 0 |