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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113748574 | 11374857 | 4 | F | 20140710 | 20160822 | 20150813 | 20160829 | PER | PHHY2014US112339 | NOVARTIS | 49.87 | YR | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113748574 | 11374857 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | 22527 | CAPSULE | |||||||||
| 113748574 | 11374857 | 2 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113748574 | 11374857 | 3 | C | LISINOPRIL HCTZ | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 113748574 | 11374857 | 4 | C | KLONOPIN | CLONAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113748574 | 11374857 | 5 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113748574 | 11374857 | 1 | Multiple sclerosis |
| 113748574 | 11374857 | 2 | Muscle spasticity |
| 113748574 | 11374857 | 3 | Hypertension |
| 113748574 | 11374857 | 4 | Seizure |
| 113748574 | 11374857 | 5 | Seizure |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113748574 | 11374857 | Blood glucose increased | |
| 113748574 | 11374857 | Blood immunoglobulin G decreased | |
| 113748574 | 11374857 | Blood sodium decreased | |
| 113748574 | 11374857 | Gastrooesophageal reflux disease | |
| 113748574 | 11374857 | Headache | |
| 113748574 | 11374857 | Hypochloraemia | |
| 113748574 | 11374857 | Hyponatraemia | |
| 113748574 | 11374857 | Insomnia | |
| 113748574 | 11374857 | Nausea | |
| 113748574 | 11374857 | Platelet count decreased | |
| 113748574 | 11374857 | Protein total decreased | |
| 113748574 | 11374857 | Sinusitis | |
| 113748574 | 11374857 | Vitamin D deficiency |
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 |
|---|---|---|---|---|---|---|
| 113748574 | 11374857 | 2 | 20151217 | 0 | ||
| 113748574 | 11374857 | 3 | 20160412 | 0 | ||
| 113748574 | 11374857 | 4 | 20160412 | 0 | ||
| 113748574 | 11374857 | 5 | 20160412 | 0 |