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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121342213 | 12134221 | 3 | F | 201512 | 20160809 | 20160301 | 20160815 | EXP | US-GLAXOSMITHKLINE-US2016GSK026879 | GLAXOSMITHKLINE | 55.80 | YR | F | Y | 116.55000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121342213 | 12134221 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | UNK, U | U | 20444 | |||||||||
| 121342213 | 12134221 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.125 MG, TID | U | 2100369 | 0 | .125 | MG | TABLET | TID | ||||
| 121342213 | 12134221 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500225A | 0 | 10 | MG | QD | ||||||
| 121342213 | 12134221 | 4 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | UNK, U | U | 0 | |||||||||
| 121342213 | 12134221 | 5 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121342213 | 12134221 | 1 | Product used for unknown indication |
| 121342213 | 12134221 | 2 | Pulmonary arterial hypertension |
| 121342213 | 12134221 | 3 | Product used for unknown indication |
| 121342213 | 12134221 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121342213 | 12134221 | Back pain | |
| 121342213 | 12134221 | Chronic sinusitis | |
| 121342213 | 12134221 | Constipation | |
| 121342213 | 12134221 | Feeling abnormal | |
| 121342213 | 12134221 | Headache | |
| 121342213 | 12134221 | Incorrect dose administered | |
| 121342213 | 12134221 | Insomnia | |
| 121342213 | 12134221 | Limb discomfort | |
| 121342213 | 12134221 | Nasal congestion | |
| 121342213 | 12134221 | Nasal discomfort | |
| 121342213 | 12134221 | Nausea | |
| 121342213 | 12134221 | Oropharyngeal pain | |
| 121342213 | 12134221 | Pain in extremity | |
| 121342213 | 12134221 | Pain in jaw | |
| 121342213 | 12134221 | Palpitations | |
| 121342213 | 12134221 | Restless legs syndrome | |
| 121342213 | 12134221 | Sinus congestion |
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 |
|---|---|---|---|---|---|---|
| 121342213 | 12134221 | 2 | 20151209 | 0 | ||
| 121342213 | 12134221 | 3 | 20071107 | 0 |