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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108607485 | 10860748 | 5 | F | 20130604 | 20160901 | 20150224 | 20160909 | EXP | PHHY2015DE019452 | NOVARTIS | 31.42 | YR | F | Y | 0.00000 | 20160909 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108607485 | 10860748 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 108607485 | 10860748 | 2 | SS | LEMTRADA | ALEMTUZUMAB | 1 | Intravenous drip | U | 0 | ||||||||||
| 108607485 | 10860748 | 3 | C | L-THYROXINE | LEVOTHYROXINE | 1 | Oral | 50 UG, QD (1-0-0) | U | 0 | 50 | UG | QD | ||||||
| 108607485 | 10860748 | 4 | C | EMSELEX | DARIFENACIN HYDROBROMIDE | 1 | Oral | 7.5 MG, QD (0-0-1) | U | 0 | 7.5 | MG | QD | ||||||
| 108607485 | 10860748 | 5 | C | EMSELEX | DARIFENACIN HYDROBROMIDE | 1 | Oral | 15 MG, QD (1-0-0) | U | 0 | 15 | MG | QD | ||||||
| 108607485 | 10860748 | 6 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, (2-0-0 ) | U | 0 | 40 | MG | |||||||
| 108607485 | 10860748 | 7 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, 1-0-0 | U | 0 | 40 | MG | |||||||
| 108607485 | 10860748 | 8 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 60 MG, QD (1-0-0 ) | Y | 0 | 60 | MG | QD | ||||||
| 108607485 | 10860748 | 9 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | 7.5 MG, UNK | U | 0 | 7.5 | MG | |||||||
| 108607485 | 10860748 | 10 | C | SPASMEX | TROSPIUM CHLORIDE | 1 | Unknown | Y | 0 | ||||||||||
| 108607485 | 10860748 | 11 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | UNK | Y | 0 | |||||||||
| 108607485 | 10860748 | 12 | C | FENISTIL | DIMETHINDENE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 108607485 | 10860748 | 13 | C | RANITIDIN | RANITIDINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 108607485 | 10860748 | 14 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108607485 | 10860748 | 1 | Multiple sclerosis |
| 108607485 | 10860748 | 2 | Product used for unknown indication |
| 108607485 | 10860748 | 3 | Product used for unknown indication |
| 108607485 | 10860748 | 4 | Product used for unknown indication |
| 108607485 | 10860748 | 6 | Product used for unknown indication |
| 108607485 | 10860748 | 8 | Product used for unknown indication |
| 108607485 | 10860748 | 9 | Product used for unknown indication |
| 108607485 | 10860748 | 10 | Product used for unknown indication |
| 108607485 | 10860748 | 11 | Prophylaxis |
| 108607485 | 10860748 | 12 | Prophylaxis |
| 108607485 | 10860748 | 13 | Prophylaxis |
| 108607485 | 10860748 | 14 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108607485 | 10860748 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108607485 | 10860748 | Affect lability | |
| 108607485 | 10860748 | Aspartate aminotransferase increased | |
| 108607485 | 10860748 | Blood albumin increased | |
| 108607485 | 10860748 | Blood cholesterol increased | |
| 108607485 | 10860748 | Blood lactate dehydrogenase increased | |
| 108607485 | 10860748 | Body temperature increased | |
| 108607485 | 10860748 | Borderline personality disorder | |
| 108607485 | 10860748 | CSF test abnormal | |
| 108607485 | 10860748 | Central nervous system lesion | |
| 108607485 | 10860748 | Clonus | |
| 108607485 | 10860748 | Coma | |
| 108607485 | 10860748 | Depressed level of consciousness | |
| 108607485 | 10860748 | Depression | |
| 108607485 | 10860748 | Disturbance in attention | |
| 108607485 | 10860748 | Dyskinesia | |
| 108607485 | 10860748 | Epilepsy | |
| 108607485 | 10860748 | Extensor plantar response | |
| 108607485 | 10860748 | Gait disturbance | |
| 108607485 | 10860748 | Haematocrit decreased | |
| 108607485 | 10860748 | Haemoglobin decreased | |
| 108607485 | 10860748 | Heart rate decreased | |
| 108607485 | 10860748 | High density lipoprotein increased | |
| 108607485 | 10860748 | Hyperreflexia | |
| 108607485 | 10860748 | Hypoacusis | |
| 108607485 | 10860748 | Hypoaesthesia | |
| 108607485 | 10860748 | Influenza like illness | |
| 108607485 | 10860748 | Limb discomfort | |
| 108607485 | 10860748 | Mean cell haemoglobin decreased | |
| 108607485 | 10860748 | Mean cell volume decreased | |
| 108607485 | 10860748 | Monoparesis | |
| 108607485 | 10860748 | Muscle spasticity | |
| 108607485 | 10860748 | Myoclonus | |
| 108607485 | 10860748 | Pain | |
| 108607485 | 10860748 | Paresis | |
| 108607485 | 10860748 | Pyramidal tract syndrome | |
| 108607485 | 10860748 | Respiratory failure | |
| 108607485 | 10860748 | Saccadic eye movement | |
| 108607485 | 10860748 | Speech disorder | |
| 108607485 | 10860748 | Visual acuity reduced | |
| 108607485 | 10860748 | Visual pathway disorder | |
| 108607485 | 10860748 | 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 |
|---|---|---|---|---|---|---|
| 108607485 | 10860748 | 1 | 20130430 | 20140510 | 0 | |
| 108607485 | 10860748 | 3 | 2010 | 0 | ||
| 108607485 | 10860748 | 6 | 20130430 | 0 | ||
| 108607485 | 10860748 | 11 | 20140820 | 20140830 | 0 | |
| 108607485 | 10860748 | 12 | 20140820 | 20140822 | 0 | |
| 108607485 | 10860748 | 13 | 20140820 | 20140822 | 0 | |
| 108607485 | 10860748 | 14 | 20140820 | 20140822 | 0 |