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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111045398 | 11104539 | 8 | F | 20140419 | 20160623 | 20150511 | 20160701 | EXP | PHHY2015IT052559 | NOVARTIS | 48.22 | YR | F | Y | 70.00000 | KG | 20160701 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111045398 | 11104539 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 259 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 111045398 | 11104539 | 2 | C | STILNOX | ZOLPIDEM TARTRATE | 1 | Unknown | U | 0 | ||||||||||
| 111045398 | 11104539 | 3 | C | DELTACORTENE | PREDNISONE | 1 | Unknown | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 111045398 | 11104539 | 4 | C | DELTACORTENE | PREDNISONE | 1 | Unknown | 62.5 MG, QD | U | 0 | 62.5 | MG | QD | ||||||
| 111045398 | 11104539 | 5 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG | U | 0 | 40 | MG | |||||||
| 111045398 | 11104539 | 6 | C | ALANERV | DIETARY SUPPLEMENT | 1 | Unknown | 1 DF | U | 0 | 1 | DF | |||||||
| 111045398 | 11104539 | 7 | C | CASPOFUNGINE | 2 | Unknown | 50 MG | Y | 0 | 50 | MG | ||||||||
| 111045398 | 11104539 | 8 | C | AMBISONE | AMPHOTERICIN B | 1 | Unknown | 350 MG | Y | 0 | 350 | MG | |||||||
| 111045398 | 11104539 | 9 | C | URBASON /GFR/ | METHYLPREDNISOLONE | 1 | Unknown | 40 MG, UNK | Y | 0 | 40 | MG | |||||||
| 111045398 | 11104539 | 10 | C | URBASON /GFR/ | METHYLPREDNISOLONE | 1 | Unknown | 80 MG, UNK | Y | 0 | 80 | MG | |||||||
| 111045398 | 11104539 | 11 | C | ALBUMIN | ALBUMIN HUMAN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111045398 | 11104539 | 1 | Multiple sclerosis |
| 111045398 | 11104539 | 2 | Product used for unknown indication |
| 111045398 | 11104539 | 3 | Product used for unknown indication |
| 111045398 | 11104539 | 5 | Product used for unknown indication |
| 111045398 | 11104539 | 6 | Product used for unknown indication |
| 111045398 | 11104539 | 7 | Product used for unknown indication |
| 111045398 | 11104539 | 8 | Product used for unknown indication |
| 111045398 | 11104539 | 9 | Product used for unknown indication |
| 111045398 | 11104539 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111045398 | 11104539 | HO |
| 111045398 | 11104539 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111045398 | 11104539 | Asthenia | |
| 111045398 | 11104539 | Autoimmune haemolytic anaemia | |
| 111045398 | 11104539 | Blood lactate dehydrogenase increased | |
| 111045398 | 11104539 | Escherichia urinary tract infection | |
| 111045398 | 11104539 | Evans syndrome | |
| 111045398 | 11104539 | Haemolysis | |
| 111045398 | 11104539 | Haemorrhagic diathesis | |
| 111045398 | 11104539 | Hepatomegaly | |
| 111045398 | 11104539 | Low density lipoprotein increased | |
| 111045398 | 11104539 | Neutropenia | |
| 111045398 | 11104539 | Oedema peripheral | |
| 111045398 | 11104539 | Paraesthesia | |
| 111045398 | 11104539 | Pyrexia | |
| 111045398 | 11104539 | Thrombocytopenia | |
| 111045398 | 11104539 | Tremor | |
| 111045398 | 11104539 | Urosepsis | |
| 111045398 | 11104539 | Uterine polyp | |
| 111045398 | 11104539 | Viral infection | |
| 111045398 | 11104539 | Vulvovaginal candidiasis |
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 |
|---|---|---|---|---|---|---|
| 111045398 | 11104539 | 1 | 20131018 | 20150319 | 0 | |
| 111045398 | 11104539 | 7 | 20150506 | 20150508 | 0 | |
| 111045398 | 11104539 | 8 | 20150508 | 20150513 | 0 | |
| 111045398 | 11104539 | 9 | 20150515 | 20150519 | 0 | |
| 111045398 | 11104539 | 10 | 20150520 | 20150522 | 0 |