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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604042 | 12660404 | 2 | F | 20150126 | 20160920 | 20160817 | 20160930 | EXP | 000642189 | CA-VALIDUS PHARMACEUTICALS LLC-CA-2016VAL002418 | VALIDUS | 54.00 | YR | F | Y | 0.00000 | 20160930 | PH | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604042 | 12660404 | 1 | PS | MEPERIDINE HYDROCHLORIDE. | MEPERIDINE HYDROCHLORIDE | 1 | Oral | UNK | U | UNKNOWN | 5010 | ||||||||
| 126604042 | 12660404 | 2 | SS | ATASOL | ACETAMINOPHEN | 1 | Oral | UNK | Y | UNKNOWN | 0 | TABLET | |||||||
| 126604042 | 12660404 | 3 | SS | CIPRALEX | ESCITALOPRAM OXALATE | 1 | Oral | 1.5 DF, QD | 534 | DF | Y | UNKNOWN | 0 | 1.5 | DF | TABLET | |||
| 126604042 | 12660404 | 4 | SS | CIPRALEX | ESCITALOPRAM OXALATE | 1 | Unknown | UNK | 534 | DF | Y | UNKNOWN | 0 | TABLET | |||||
| 126604042 | 12660404 | 5 | SS | CIPRALEX | ESCITALOPRAM OXALATE | 1 | UNK | 534 | DF | Y | 0 | TABLET | |||||||
| 126604042 | 12660404 | 6 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 18 MG, QD | 1494 | MG | Y | UNKNOWN | 0 | 18 | MG | ||||
| 126604042 | 12660404 | 7 | SS | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Intravenous (not otherwise specified) | UNK | U | UNKNOWN | 0 | ||||||||
| 126604042 | 12660404 | 8 | C | DIPROSONE | BETAMETHASONE DIPROPIONATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 9 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 10 | C | GLUCAGON. | GLUCAGON | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 11 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 13 | C | PHISOHEX | HEXACHLOROPHENE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 14 | C | PROCTODAN HC | 2 | Unknown | UNK | U | 0 | ||||||||||
| 126604042 | 12660404 | 15 | C | PROCTOSOL HC | 2 | Unknown | UNK | U | 0 | ||||||||||
| 126604042 | 12660404 | 16 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 17 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126604042 | 12660404 | 18 | C | TECTA | PANTOPRAZOLE MAGNESIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126604042 | 12660404 | 1 | Pain |
| 126604042 | 12660404 | 2 | Pain |
| 126604042 | 12660404 | 3 | Depression |
| 126604042 | 12660404 | 6 | Product used for unknown indication |
| 126604042 | 12660404 | 7 | Surgery |
| 126604042 | 12660404 | 8 | Product used for unknown indication |
| 126604042 | 12660404 | 9 | Product used for unknown indication |
| 126604042 | 12660404 | 10 | Product used for unknown indication |
| 126604042 | 12660404 | 11 | Product used for unknown indication |
| 126604042 | 12660404 | 12 | Product used for unknown indication |
| 126604042 | 12660404 | 13 | Product used for unknown indication |
| 126604042 | 12660404 | 14 | Product used for unknown indication |
| 126604042 | 12660404 | 15 | Product used for unknown indication |
| 126604042 | 12660404 | 16 | Product used for unknown indication |
| 126604042 | 12660404 | 17 | Product used for unknown indication |
| 126604042 | 12660404 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126604042 | 12660404 | LT |
| 126604042 | 12660404 | OT |
| 126604042 | 12660404 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126604042 | 12660404 | Agitation | |
| 126604042 | 12660404 | Body temperature increased | |
| 126604042 | 12660404 | Diarrhoea | |
| 126604042 | 12660404 | Flushing | |
| 126604042 | 12660404 | Hallucination, auditory | |
| 126604042 | 12660404 | Hallucination, visual | |
| 126604042 | 12660404 | Insomnia | |
| 126604042 | 12660404 | Rash | |
| 126604042 | 12660404 | Serotonin syndrome |
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 |
|---|---|---|---|---|---|---|
| 126604042 | 12660404 | 1 | 20150119 | 20150123 | 0 | |
| 126604042 | 12660404 | 2 | 20150123 | 20150124 | 0 | |
| 126604042 | 12660404 | 3 | 20140204 | 20150126 | 0 | |
| 126604042 | 12660404 | 4 | 20150202 | 20150204 | 0 | |
| 126604042 | 12660404 | 6 | 20141104 | 20150126 | 0 | |
| 126604042 | 12660404 | 7 | 20150119 | 20150119 | 0 |