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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119138416 | 11913841 | 6 | F | 201605 | 20160701 | 20160113 | 20160706 | EXP | US-GILEAD-2016-0192190 | GILEAD | 43.00 | YR | A | F | Y | 0.00000 | 20160706 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119138416 | 11913841 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | SBFX | 22081 | 10 | MG | TABLET | QD | |||||
| 119138416 | 11913841 | 2 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | U | 0 | ||||||||||
| 119138416 | 11913841 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Unknown | U | 0 | ||||||||||
| 119138416 | 11913841 | 4 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119138416 | 11913841 | 1 | Product used for unknown indication |
| 119138416 | 11913841 | 2 | Product used for unknown indication |
| 119138416 | 11913841 | 3 | Product used for unknown indication |
| 119138416 | 11913841 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119138416 | 11913841 | OT |
| 119138416 | 11913841 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119138416 | 11913841 | Cellulitis | |
| 119138416 | 11913841 | Diarrhoea | |
| 119138416 | 11913841 | Headache | |
| 119138416 | 11913841 | Infusion site cellulitis | |
| 119138416 | 11913841 | Syncope | |
| 119138416 | 11913841 | Therapy change |
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 |
|---|---|---|---|---|---|---|
| 119138416 | 11913841 | 1 | 20150902 | 0 |