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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115155453 | 11515545 | 3 | F | 20150717 | 20160908 | 20150916 | 20160920 | EXP | US-ACTELION-A-NJ2013-89090 | ACTELION | 27.00 | YR | A | M | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115155453 | 11515545 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 31.25 MG, BID | DP046P0602, NP010A0101,NP011A0101 | 21290 | 31.25 | MG | TABLET | BID | |||||
| 115155453 | 11515545 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | AP08P0601, DP046P0602, NP010A0101 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 115155453 | 11515545 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 31.25 MG, QD | AP08P0601, DP046P0602, NP010A0101 | 21290 | 31.25 | MG | TABLET | QD | |||||
| 115155453 | 11515545 | 4 | SS | HYDROXYUREA. | HYDROXYUREA | 1 | Unknown | 500 MG, BID | Y | 0 | 500 | MG | BID | ||||||
| 115155453 | 11515545 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 6 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 7 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 8 | C | WARFARIN | WARFARIN | 1 | UNK | U | 0 | ||||||||||
| 115155453 | 11515545 | 9 | C | EXJADE | DEFERASIROX | 1 | 100 MG, QPM | U | 0 | 100 | MG | QD | |||||||
| 115155453 | 11515545 | 10 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 11 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 115155453 | 11515545 | 13 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 14 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | U | 0 | |||||||||||
| 115155453 | 11515545 | 15 | C | MORPHINE | MORPHINE | 1 | UNK | U | 0 | ||||||||||
| 115155453 | 11515545 | 16 | C | OXYCODONE | OXYCODONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115155453 | 11515545 | 1 | Pulmonary arterial hypertension |
| 115155453 | 11515545 | 4 | Sickle cell anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115155453 | 11515545 | OT |
| 115155453 | 11515545 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115155453 | 11515545 | Dyspnoea | |
| 115155453 | 11515545 | Haemolytic anaemia | |
| 115155453 | 11515545 | Pain | |
| 115155453 | 11515545 | Pancytopenia | |
| 115155453 | 11515545 | Pneumonia | |
| 115155453 | 11515545 | Sepsis | |
| 115155453 | 11515545 | Sickle cell anaemia with crisis | |
| 115155453 | 11515545 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 115155453 | 11515545 | 1 | 200807 | 0 | ||
| 115155453 | 11515545 | 2 | 20100226 | 0 | ||
| 115155453 | 11515545 | 3 | 20100729 | 0 |