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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112801 | 12711280 | 1 | I | 20160801 | 20160825 | 20160902 | 20160902 | EXP | FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-072241 | BRISTOL MYERS SQUIBB | 76.00 | YR | F | Y | 0.00000 | 20160902 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127112801 | 12711280 | 1 | PS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 5 MG, QD | 40 | MG | Y | 21436 | 5 | MG | TABLET | QD | |||
| 127112801 | 12711280 | 2 | SS | TERALITHE | LITHIUM CARBONATE | 1 | Oral | 600 MG, QD | 3600 | MG | Y | 0 | 600 | MG | TABLET | QD | |||
| 127112801 | 12711280 | 3 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 160 MG, BID | 26880 | MG | Y | 0 | 160 | MG | GASTRO-RESISTANT CAPSULE | BID | |||
| 127112801 | 12711280 | 4 | C | TEMESTA /00273201/ | LORAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 127112801 | 12711280 | 5 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127112801 | 12711280 | 6 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127112801 | 12711280 | 1 | Major depression |
| 127112801 | 12711280 | 2 | Major depression |
| 127112801 | 12711280 | 3 | Major depression |
| 127112801 | 12711280 | 4 | Product used for unknown indication |
| 127112801 | 12711280 | 5 | Product used for unknown indication |
| 127112801 | 12711280 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127112801 | 12711280 | OT |
| 127112801 | 12711280 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127112801 | 12711280 | Product use issue | |
| 127112801 | 12711280 | 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 |
|---|---|---|---|---|---|---|
| 127112801 | 12711280 | 1 | 20160725 | 20160801 | 0 | |
| 127112801 | 12711280 | 2 | 20160727 | 20160801 | 0 | |
| 127112801 | 12711280 | 3 | 20160510 | 20160801 | 0 |