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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115997544 | 11599754 | 4 | F | 20150430 | 20160907 | 20151006 | 20160919 | PER | PHEH2015US010095 | NOVARTIS | 48.11 | YR | M | Y | 98.42000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115997544 | 11599754 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 115997544 | 11599754 | 2 | C | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | Unknown | U | 0 | ||||||||||
| 115997544 | 11599754 | 3 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | U | 0 | ||||||||||
| 115997544 | 11599754 | 4 | C | LYRICA | PREGABALIN | 1 | Unknown | 150 MG, BID | U | 0 | 150 | MG | BID | ||||||
| 115997544 | 11599754 | 5 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 37.5 MG, QD | U | 0 | 37.5 | MG | QD | ||||||
| 115997544 | 11599754 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, UNK | U | 0 | 300 | MG | |||||||
| 115997544 | 11599754 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115997544 | 11599754 | 1 | Multiple sclerosis |
| 115997544 | 11599754 | 2 | Product used for unknown indication |
| 115997544 | 11599754 | 3 | Product used for unknown indication |
| 115997544 | 11599754 | 4 | Product used for unknown indication |
| 115997544 | 11599754 | 5 | Product used for unknown indication |
| 115997544 | 11599754 | 6 | Product used for unknown indication |
| 115997544 | 11599754 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115997544 | 11599754 | Anger | |
| 115997544 | 11599754 | Anxiety | |
| 115997544 | 11599754 | Aphasia | |
| 115997544 | 11599754 | Ataxia | |
| 115997544 | 11599754 | Back pain | |
| 115997544 | 11599754 | Burning sensation | |
| 115997544 | 11599754 | Depression | |
| 115997544 | 11599754 | Disturbance in attention | |
| 115997544 | 11599754 | Fall | |
| 115997544 | 11599754 | Fatigue | |
| 115997544 | 11599754 | Gait disturbance | |
| 115997544 | 11599754 | Gait spastic | |
| 115997544 | 11599754 | General physical health deterioration | |
| 115997544 | 11599754 | Headache | |
| 115997544 | 11599754 | Irritability | |
| 115997544 | 11599754 | Memory impairment | |
| 115997544 | 11599754 | Muscle spasms | |
| 115997544 | 11599754 | Muscle tightness | |
| 115997544 | 11599754 | Muscular weakness | |
| 115997544 | 11599754 | Nocturia | |
| 115997544 | 11599754 | Pain | |
| 115997544 | 11599754 | Paraesthesia | |
| 115997544 | 11599754 | Scoliosis | |
| 115997544 | 11599754 | Sensory loss | |
| 115997544 | 11599754 | Sleep apnoea syndrome | |
| 115997544 | 11599754 | Sleep disorder | |
| 115997544 | 11599754 | Stress | |
| 115997544 | 11599754 | Urinary hesitation | |
| 115997544 | 11599754 | Weight 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 |
|---|---|---|---|---|---|---|
| 115997544 | 11599754 | 1 | 20150430 | 0 |