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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484681 | 12548468 | 1 | I | 20160703 | 0 | 20160711 | 20160711 | DIR | 89.00 | YR | M | N | 63.00000 | KG | 20160707 | N | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484681 | 12548468 | 1 | PS | COLACE | DOCUSATE SODIUM | 1 | Oral | D | D | 0 | 100 | MG | TID | ||||||
| 125484681 | 12548468 | 2 | SS | COLACE | DOCUSATE SODIUM | 1 | D | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125484681 | 12548468 | 1 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125484681 | 12548468 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125484681 | 12548468 | Burkholderia test positive | |
| 125484681 | 12548468 | Product contamination microbial | |
| 125484681 | 12548468 | Sputum culture positive |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 125484681 | 12548468 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125484681 | 12548468 | 1 | 20160627 | 20160701 | 0 |