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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105545596 | 10554559 | 6 | F | 20141022 | 20160815 | 20141030 | 20160822 | EXP | US-GLAXOSMITHKLINE-US2014GSK013986 | GLAXOSMITHKLINE | 11.82 | YR | M | Y | 0.00000 | 20160822 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105545596 | 10554559 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 269 NG/KG/MIN, CO | S967 | 20444 | 269 | DF | POWDER FOR INFUSION | ||||||
| 105545596 | 10554559 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 158 NG/KG/MIN | U631 | 20444 | POWDER FOR INFUSION | ||||||||
| 105545596 | 10554559 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 166 NG/KG/MIN, CONTINUOUSLY | Z880 | 20444 | 166 | DF | POWDER FOR INFUSION | ||||||
| 105545596 | 10554559 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | 31320112B | 0 | SOLUTION FOR INJECTION | |||||||||
| 105545596 | 10554559 | 5 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | Y | 0 | ||||||||||
| 105545596 | 10554559 | 6 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105545596 | 10554559 | 1 | Pulmonary arterial hypertension |
| 105545596 | 10554559 | 4 | Pulmonary arterial hypertension |
| 105545596 | 10554559 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105545596 | 10554559 | OT |
| 105545596 | 10554559 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105545596 | 10554559 | Coxsackie viral infection | |
| 105545596 | 10554559 | Device related infection | |
| 105545596 | 10554559 | Diarrhoea | |
| 105545596 | 10554559 | Headache | |
| 105545596 | 10554559 | Hospitalisation | |
| 105545596 | 10554559 | Influenza virus test positive | |
| 105545596 | 10554559 | Nausea | |
| 105545596 | 10554559 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 105545596 | 10554559 | 1 | 20061218 | 0 | ||
| 105545596 | 10554559 | 2 | 20061218 | 0 | ||
| 105545596 | 10554559 | 3 | 20061218 | 0 |