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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124936933 | 12493693 | 3 | F | 20160621 | 20160715 | 20160623 | 20160720 | PER | PHEH2016US015635 | NOVARTIS | 58.73 | YR | F | Y | 0.00000 | 20160720 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124936933 | 12493693 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, 1 DF, QD | F0035 | 22527 | 1 | DF | CAPSULE | QD | |||||
| 124936933 | 12493693 | 2 | C | PROTINEX | 2 | Unknown | U | 0 | |||||||||||
| 124936933 | 12493693 | 3 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 4 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 5 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 6 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 7 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 8 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 9 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 11 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 124936933 | 12493693 | 12 | C | VALIUM | DIAZEPAM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124936933 | 12493693 | 1 | Multiple sclerosis |
| 124936933 | 12493693 | 2 | Product used for unknown indication |
| 124936933 | 12493693 | 3 | Product used for unknown indication |
| 124936933 | 12493693 | 4 | Product used for unknown indication |
| 124936933 | 12493693 | 5 | Product used for unknown indication |
| 124936933 | 12493693 | 6 | Product used for unknown indication |
| 124936933 | 12493693 | 7 | Product used for unknown indication |
| 124936933 | 12493693 | 8 | Product used for unknown indication |
| 124936933 | 12493693 | 9 | Product used for unknown indication |
| 124936933 | 12493693 | 10 | Product used for unknown indication |
| 124936933 | 12493693 | 11 | Product used for unknown indication |
| 124936933 | 12493693 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124936933 | 12493693 | Dyspepsia | |
| 124936933 | 12493693 | Feeling abnormal | |
| 124936933 | 12493693 | Myalgia | |
| 124936933 | 12493693 | Nausea | |
| 124936933 | 12493693 | Pain | |
| 124936933 | 12493693 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 124936933 | 12493693 | 1 | 20160621 | 0 |