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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113795485 | 11379548 | 5 | F | 20141021 | 20160817 | 20150814 | 20160823 | PER | PHHY2015US067871 | NOVARTIS | 41.14 | YR | F | Y | 61.20000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113795485 | 11379548 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 113795485 | 11379548 | 2 | SS | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | Y | 0 | ||||||||||
| 113795485 | 11379548 | 3 | SS | MORPHINE | MORPHINE | 1 | Y | 0 | |||||||||||
| 113795485 | 11379548 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 400 U, QD | U | 0 | 400 | DF | TABLET | QD | |||||
| 113795485 | 11379548 | 5 | C | LIORESAL | BACLOFEN | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | BID | |||||
| 113795485 | 11379548 | 6 | C | LIORESAL | BACLOFEN | 1 | U | 0 | TABLET | ||||||||||
| 113795485 | 11379548 | 7 | C | DELTASONE | PREDNISONE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 113795485 | 11379548 | 8 | C | LYRICA | PREGABALIN | 1 | Oral | 100 MG, QD | 0 | 100 | MG | CAPSULE | QD | ||||||
| 113795485 | 11379548 | 9 | C | LYRICA | PREGABALIN | 1 | Oral | 50,50, 100 MG, PER DAY | 0 | 150 | MG | CAPSULE | |||||||
| 113795485 | 11379548 | 10 | C | SYMMETREL | AMANTADINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 113795485 | 11379548 | 11 | C | AZULFIDINE | SULFASALAZINE | 1 | Unknown | 0 | |||||||||||
| 113795485 | 11379548 | 12 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 10 MG, BID | 0 | 10 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113795485 | 11379548 | 1 | Relapsing-remitting multiple sclerosis |
| 113795485 | 11379548 | 2 | Neuralgia |
| 113795485 | 11379548 | 3 | Multiple sclerosis relapse |
| 113795485 | 11379548 | 4 | Vitamin D deficiency |
| 113795485 | 11379548 | 5 | Muscle spasticity |
| 113795485 | 11379548 | 6 | Pain |
| 113795485 | 11379548 | 7 | Product used for unknown indication |
| 113795485 | 11379548 | 8 | Multiple sclerosis |
| 113795485 | 11379548 | 9 | Pain |
| 113795485 | 11379548 | 10 | Product used for unknown indication |
| 113795485 | 11379548 | 11 | Product used for unknown indication |
| 113795485 | 11379548 | 12 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113795485 | 11379548 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113795485 | 11379548 | Anxiety | |
| 113795485 | 11379548 | Arthritis | |
| 113795485 | 11379548 | Asthenia | |
| 113795485 | 11379548 | Balance disorder | |
| 113795485 | 11379548 | Carbon dioxide increased | |
| 113795485 | 11379548 | Constipation | |
| 113795485 | 11379548 | Fatigue | |
| 113795485 | 11379548 | Gait disturbance | |
| 113795485 | 11379548 | Haematocrit decreased | |
| 113795485 | 11379548 | Haemoglobin decreased | |
| 113795485 | 11379548 | Hallucination, visual | |
| 113795485 | 11379548 | Hemiparesis | |
| 113795485 | 11379548 | Multiple sclerosis relapse | |
| 113795485 | 11379548 | Muscle spasms | |
| 113795485 | 11379548 | Musculoskeletal pain | |
| 113795485 | 11379548 | Musculoskeletal stiffness | |
| 113795485 | 11379548 | Pain | |
| 113795485 | 11379548 | Red blood cell count decreased | |
| 113795485 | 11379548 | Temperature intolerance |
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 |
|---|---|---|---|---|---|---|
| 113795485 | 11379548 | 1 | 20140806 | 0 | ||
| 113795485 | 11379548 | 2 | 20151108 | 20151113 | 0 | |
| 113795485 | 11379548 | 8 | 2008 | 0 | ||
| 113795485 | 11379548 | 12 | 20131106 | 0 |