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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114294827 | 11429482 | 7 | F | 20150203 | 20160825 | 20150828 | 20160831 | PER | PHHY2015US023512 | NOVARTIS | 43.54 | YR | F | Y | 77.55000 | KG | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114294827 | 11429482 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 114294827 | 11429482 | 2 | SS | LISINOPRIL. | LISINOPRIL | 1 | Unknown | UNK | Y | 0 | |||||||||
| 114294827 | 11429482 | 3 | C | VIMPAT | LACOSAMIDE | 1 | Unknown | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 114294827 | 11429482 | 4 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 114294827 | 11429482 | 5 | C | VALIUM | DIAZEPAM | 1 | Oral | 5 MG, PRN | U | 0 | 5 | MG | |||||||
| 114294827 | 11429482 | 6 | C | VALIUM | DIAZEPAM | 1 | Unknown | 10 MG, PRN | U | 0 | 10 | MG | |||||||
| 114294827 | 11429482 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 5000 IU, PRN | U | 0 | 5000 | IU | |||||||
| 114294827 | 11429482 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 40 OT, QD | U | 0 | QD | ||||||||
| 114294827 | 11429482 | 9 | C | INTRAX | 2 | Oral | 50 MG, UNK | U | 0 | 50 | MG | ||||||||
| 114294827 | 11429482 | 10 | C | BENADRYL /00647601/ | CAMPHORDIPHENHYDRAMINEINC OXIDE | 1 | Unknown | 25 G, UNK | U | 0 | 25 | G | |||||||
| 114294827 | 11429482 | 11 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 114294827 | 11429482 | 12 | C | MAGNESIUM | MAGNESIUM | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 114294827 | 11429482 | 13 | C | NICODIN//HYDROXYMETHYLNICOTINAMIDE | 2 | Unknown | 14 MG, UNK | U | 0 | 14 | MG | PATCH | |||||||
| 114294827 | 11429482 | 14 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | Oral | 25 MG, PRN | U | 0 | 25 | MG | SYRUP | ||||||
| 114294827 | 11429482 | 15 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | Unknown | U | 0 | SHAMPOO | |||||||||
| 114294827 | 11429482 | 16 | C | VALACYCLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 114294827 | 11429482 | 17 | C | CARAFATE | SUCRALFATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114294827 | 11429482 | 1 | Multiple sclerosis |
| 114294827 | 11429482 | 2 | Blood pressure increased |
| 114294827 | 11429482 | 3 | Partial seizures |
| 114294827 | 11429482 | 4 | Product used for unknown indication |
| 114294827 | 11429482 | 5 | Product used for unknown indication |
| 114294827 | 11429482 | 7 | Product used for unknown indication |
| 114294827 | 11429482 | 8 | Product used for unknown indication |
| 114294827 | 11429482 | 9 | Product used for unknown indication |
| 114294827 | 11429482 | 10 | Prophylaxis |
| 114294827 | 11429482 | 11 | Dystonia |
| 114294827 | 11429482 | 13 | Product used for unknown indication |
| 114294827 | 11429482 | 14 | Product used for unknown indication |
| 114294827 | 11429482 | 15 | Psoriasis |
| 114294827 | 11429482 | 16 | Oral herpes |
| 114294827 | 11429482 | 17 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114294827 | 11429482 | HO |
| 114294827 | 11429482 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114294827 | 11429482 | Alanine aminotransferase increased | |
| 114294827 | 11429482 | Aspartate aminotransferase increased | |
| 114294827 | 11429482 | Blood cholesterol increased | |
| 114294827 | 11429482 | Blood pressure increased | |
| 114294827 | 11429482 | Bradycardia | |
| 114294827 | 11429482 | Cough | |
| 114294827 | 11429482 | Diarrhoea | |
| 114294827 | 11429482 | Gastroenteritis viral | |
| 114294827 | 11429482 | Hypokalaemia | |
| 114294827 | 11429482 | Hypomagnesaemia | |
| 114294827 | 11429482 | Incision site infection | |
| 114294827 | 11429482 | Lymphocyte count decreased | |
| 114294827 | 11429482 | Migraine | |
| 114294827 | 11429482 | Multiple sclerosis relapse | |
| 114294827 | 11429482 | Muscle spasms | |
| 114294827 | 11429482 | Nausea | |
| 114294827 | 11429482 | Pain | |
| 114294827 | 11429482 | Procedural pain | |
| 114294827 | 11429482 | Pyrexia | |
| 114294827 | 11429482 | Vomiting | |
| 114294827 | 11429482 | 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 |
|---|---|---|---|---|---|---|
| 114294827 | 11429482 | 1 | 20150203 | 0 | ||
| 114294827 | 11429482 | 2 | 20160107 | 20160114 | 0 | |
| 114294827 | 11429482 | 3 | 201409 | 0 | ||
| 114294827 | 11429482 | 4 | 20130325 | 0 | ||
| 114294827 | 11429482 | 5 | 2006 | 0 | ||
| 114294827 | 11429482 | 6 | 2006 | 0 | ||
| 114294827 | 11429482 | 11 | 20111102 | 0 | ||
| 114294827 | 11429482 | 16 | 20150227 | 0 | ||
| 114294827 | 11429482 | 17 | 20150227 | 0 |