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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124329433 | 12432943 | 3 | F | 20160428 | 20160711 | 20160603 | 20160720 | EXP | PHEH2016US013630 | SANDOZ | 60.60 | YR | M | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124329433 | 12432943 | 1 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK, QOD | 0 | CAPSULE | |||||||||
| 124329433 | 12432943 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK, QOD | 0 | CAPSULE | |||||||||
| 124329433 | 12432943 | 3 | PS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, BID (TOOK 600 MG AT BEDTIME) | 75539 | 300 | MG | BID | |||||||
| 124329433 | 12432943 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 900 MG, UNK | 75539 | 900 | MG | ||||||||
| 124329433 | 12432943 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 10000 IU, QD | U | 0 | 10000 | IU | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124329433 | 12432943 | 1 | Product used for unknown indication |
| 124329433 | 12432943 | 3 | Product used for unknown indication |
| 124329433 | 12432943 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124329433 | 12432943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124329433 | 12432943 | Abdominal discomfort | |
| 124329433 | 12432943 | Aphasia | |
| 124329433 | 12432943 | Burning sensation | |
| 124329433 | 12432943 | Crohn's disease | |
| 124329433 | 12432943 | Decreased appetite | |
| 124329433 | 12432943 | Decreased vibratory sense | |
| 124329433 | 12432943 | Diarrhoea | |
| 124329433 | 12432943 | Dizziness | |
| 124329433 | 12432943 | Drug intolerance | |
| 124329433 | 12432943 | Fatigue | |
| 124329433 | 12432943 | Feeling abnormal | |
| 124329433 | 12432943 | Grip strength decreased | |
| 124329433 | 12432943 | Headache | |
| 124329433 | 12432943 | Hyperreflexia | |
| 124329433 | 12432943 | Hypotonia | |
| 124329433 | 12432943 | Limb discomfort | |
| 124329433 | 12432943 | Muscle spasms | |
| 124329433 | 12432943 | Muscle spasticity | |
| 124329433 | 12432943 | Muscle tightness | |
| 124329433 | 12432943 | Musculoskeletal stiffness | |
| 124329433 | 12432943 | Nausea | |
| 124329433 | 12432943 | Pain | |
| 124329433 | 12432943 | Paraesthesia | |
| 124329433 | 12432943 | Prescribed underdose | |
| 124329433 | 12432943 | Somnolence | |
| 124329433 | 12432943 | Stress | |
| 124329433 | 12432943 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124329433 | 12432943 | 1 | 20151204 | 0 |