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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120110494 | 12011049 | 4 | F | 2015 | 20160725 | 20160205 | 20160808 | EXP | US-ACORDA-ACO_121173_2016 | ACORDA | 49.92 | YR | F | Y | 70.30000 | KG | 20160808 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120110494 | 12011049 | 1 | PS | AMPYRA | DALFAMPRIDINE | 1 | Unknown | 10 MG, BID | U | 22250 | 10 | MG | TABLET | BID | |||||
| 120110494 | 12011049 | 2 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 400 MG, TID | U | 0 | 400 | MG | TID | ||||||
| 120110494 | 12011049 | 3 | C | AUBAGIO | TERIFLUNOMIDE | 1 | Unknown | 1 DF, QAM | U | 0 | 1 | DF | QD | ||||||
| 120110494 | 12011049 | 4 | C | IBRANCE | PALBOCICLIB | 1 | Unknown | UNK | U | 0 | |||||||||
| 120110494 | 12011049 | 5 | C | Diclofenac | DICLOFENAC | 1 | 1 DF, Q 8 HRS | U | 0 | 1 | DF | Q8H | |||||||
| 120110494 | 12011049 | 6 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | 5 MG, QD | U | 0 | 5 | MG | QD | |||||||
| 120110494 | 12011049 | 7 | C | BACLOFEN. | BACLOFEN | 1 | 20 MG, TID | U | 0 | 20 | MG | TID | |||||||
| 120110494 | 12011049 | 8 | C | MARINOL | DRONABINOL | 1 | Oral | 5 MG, TID | U | 0 | 5 | MG | TID | ||||||
| 120110494 | 12011049 | 9 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 1 DF, QD | U | 0 | 1 | DF | QD | |||||||
| 120110494 | 12011049 | 10 | C | FENTANYL. | FENTANYL | 1 | 75 ?G, Q 72 HRS | U | 0 | 75 | UG | TRANSDERMAL PATCH | |||||||
| 120110494 | 12011049 | 11 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 2 MG, Q 4HRS PRN | U | 0 | 2 | MG | TABLET | |||||||
| 120110494 | 12011049 | 12 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 4 MG, 1 TAB 4-6HRS PRN | U | 0 | 4 | MG | TABLET | |||||||
| 120110494 | 12011049 | 13 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | Oral | 1 DF, Q 8 HRS | U | 0 | 1 | DF | TABLET | Q8H | |||||
| 120110494 | 12011049 | 14 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120110494 | 12011049 | 1 | Multiple sclerosis |
| 120110494 | 12011049 | 2 | Product used for unknown indication |
| 120110494 | 12011049 | 3 | Product used for unknown indication |
| 120110494 | 12011049 | 4 | Product used for unknown indication |
| 120110494 | 12011049 | 5 | Product used for unknown indication |
| 120110494 | 12011049 | 6 | Product used for unknown indication |
| 120110494 | 12011049 | 7 | Product used for unknown indication |
| 120110494 | 12011049 | 8 | Product used for unknown indication |
| 120110494 | 12011049 | 9 | Product used for unknown indication |
| 120110494 | 12011049 | 10 | Product used for unknown indication |
| 120110494 | 12011049 | 11 | Product used for unknown indication |
| 120110494 | 12011049 | 12 | Product used for unknown indication |
| 120110494 | 12011049 | 13 | Product used for unknown indication |
| 120110494 | 12011049 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120110494 | 12011049 | HO |
| 120110494 | 12011049 | OT |
| 120110494 | 12011049 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120110494 | 12011049 | Anal incontinence | |
| 120110494 | 12011049 | Anxiety | |
| 120110494 | 12011049 | Breast cancer metastatic | |
| 120110494 | 12011049 | Breast pain | |
| 120110494 | 12011049 | Cardiomegaly | |
| 120110494 | 12011049 | Cervical dysplasia | |
| 120110494 | 12011049 | Chronic obstructive pulmonary disease | |
| 120110494 | 12011049 | Confusional state | |
| 120110494 | 12011049 | Depression | |
| 120110494 | 12011049 | Discomfort | |
| 120110494 | 12011049 | Dysarthria | |
| 120110494 | 12011049 | Dysphagia | |
| 120110494 | 12011049 | Fall | |
| 120110494 | 12011049 | Gait disturbance | |
| 120110494 | 12011049 | Head injury | |
| 120110494 | 12011049 | Invasive ductal breast carcinoma | |
| 120110494 | 12011049 | Mass | |
| 120110494 | 12011049 | Memory impairment | |
| 120110494 | 12011049 | Mental status changes | |
| 120110494 | 12011049 | Myocardial infarction | |
| 120110494 | 12011049 | Nausea | |
| 120110494 | 12011049 | Oedema peripheral | |
| 120110494 | 12011049 | Pain | |
| 120110494 | 12011049 | Petechiae | |
| 120110494 | 12011049 | Plantar fascial fibromatosis | |
| 120110494 | 12011049 | Pneumonia | |
| 120110494 | 12011049 | Sepsis | |
| 120110494 | 12011049 | Somnolence | |
| 120110494 | 12011049 | Tachycardia | |
| 120110494 | 12011049 | Thrombocytopenia | |
| 120110494 | 12011049 | Urinary incontinence | |
| 120110494 | 12011049 | 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 |
|---|---|---|---|---|---|---|
| 120110494 | 12011049 | 1 | 201306 | 0 |