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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126019781 | 12601978 | 1 | I | 20141204 | 20160718 | 20160728 | 20160728 | EXP | CN-JNJFOC-20160721877 | JANSSEN | 71.92 | YR | E | M | Y | 60.00000 | KG | 20160728 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126019781 | 12601978 | 1 | PS | ULTRACET | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Oral | Y | N | 130701002 | 21123 | 1 | DF | TABLETS | BID | ||||
| 126019781 | 12601978 | 2 | SS | GALAKE | ACETAMINOPHENDIHYDROCODEINE BITARTRATE | 1 | Oral | Y | 140548 | 0 | 1 | DF | TABLET | BID | |||||
| 126019781 | 12601978 | 3 | SS | GALAKE | ACETAMINOPHENDIHYDROCODEINE BITARTRATE | 1 | Oral | Y | 140548 | 0 | 1 | DF | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126019781 | 12601978 | 1 | Pain |
| 126019781 | 12601978 | 2 | Analgesic therapy |
| 126019781 | 12601978 | 3 | Cough |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126019781 | 12601978 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126019781 | 12601978 | Haemoglobin decreased | |
| 126019781 | 12601978 | Red blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 126019781 | 12601978 | 1 | 20141113 | 20141204 | 0 | |
| 126019781 | 12601978 | 2 | 20141113 | 20141204 | 0 | |
| 126019781 | 12601978 | 3 | 20141113 | 20141204 | 0 |