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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111924376 | 11192437 | 6 | F | 20150508 | 20160916 | 20150616 | 20160919 | EXP | JP-PFIZER INC-2015200409 | PFIZER | 63.00 | YR | M | Y | 43.00000 | KG | 20160919 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111924376 | 11192437 | 1 | PS | Champix 1MG | VARENICLINE TARTRATE | 1 | Oral | 0.5 MG, DAILY | D | 21928 | .5 | MG | FILM-COATED TABLET | ||||||
| 111924376 | 11192437 | 2 | SS | Champix 1MG | VARENICLINE TARTRATE | 1 | Oral | 1 MG, 2X/DAY | D | 21928 | 1 | MG | FILM-COATED TABLET | BID | |||||
| 111924376 | 11192437 | 3 | SS | Risperidone Pfizer | RISPERIDONE | 1 | Oral | 1 MG, 1X/DAY | D | 0 | 1 | MG | FILM-COATED TABLET | QD | |||||
| 111924376 | 11192437 | 4 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1.5 MG, DAILY | D | 74243 | 1.5 | MG | |||||||
| 111924376 | 11192437 | 5 | SS | BROTIZOLAM | BROTIZOLAM | 1 | Oral | 0.25 MG, 1X/DAY | 2 | MG | U | 0 | .25 | MG | TABLET | QD | |||
| 111924376 | 11192437 | 6 | SS | BROTIZOLAM | BROTIZOLAM | 1 | 2 | MG | U | 0 | TABLET | ||||||||
| 111924376 | 11192437 | 7 | SS | OPTIRAY 320 | IOVERSOL | 1 | Intravenous (not otherwise specified) | 320 MG, 1X/DAY | D | 0 | 320 | MG | QD | ||||||
| 111924376 | 11192437 | 8 | C | FLUNITRAZEPAM | FLUNITRAZEPAM | 1 | Oral | 2 MG, 1X/DAY | 28 | MG | 0 | 2 | MG | TABLET | QD | ||||
| 111924376 | 11192437 | 9 | C | TAMSULOSIN | TAMSULOSIN | 1 | Oral | 0.2 MG, 1X/DAY | 2.4000001 | MG | 0 | .2 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111924376 | 11192437 | 5 | Insomnia |
| 111924376 | 11192437 | 6 | Delirium tremens |
| 111924376 | 11192437 | 7 | Venogram |
| 111924376 | 11192437 | 8 | Insomnia |
| 111924376 | 11192437 | 9 | Pollakiuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111924376 | 11192437 | DE |
| 111924376 | 11192437 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111924376 | 11192437 | Anxiety | |
| 111924376 | 11192437 | Arrhythmia | |
| 111924376 | 11192437 | Cardiac arrest | |
| 111924376 | 11192437 | Cardio-respiratory arrest | |
| 111924376 | 11192437 | Delirium | |
| 111924376 | 11192437 | Hallucination | |
| 111924376 | 11192437 | Persecutory delusion | |
| 111924376 | 11192437 | Respiratory arrest | |
| 111924376 | 11192437 | Sudden death |
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 |
|---|---|---|---|---|---|---|
| 111924376 | 11192437 | 2 | 20150428 | 0 | ||
| 111924376 | 11192437 | 3 | 20150508 | 0 | ||
| 111924376 | 11192437 | 5 | 20150428 | 20150507 | 0 | |
| 111924376 | 11192437 | 7 | 20150512 | 0 | ||
| 111924376 | 11192437 | 8 | 20150428 | 20150511 | 0 | |
| 111924376 | 11192437 | 9 | 20150430 | 20150511 | 0 |