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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1213476112 | 12134761 | 12 | F | 20160217 | 20160804 | 20160301 | 20160816 | EXP | US-ACTELION-A-NJ2016-131681 | ACTELION | 70.00 | YR | E | M | Y | 68.27000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1213476112 | 12134761 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM016A0201;UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 1213476112 | 12134761 | 2 | SS | DIGOXIN. | DIGOXIN | 1 | Oral | 0.25 MG, QD | Y | U | 0 | .25 | MG | QD | |||||
| 1213476112 | 12134761 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | 43 NG/KG, PER MIN | U | U | 926618, 2100703 | 0 | /min | ||||||
| 1213476112 | 12134761 | 4 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | 75 MG, BID | U | 0 | 75 | MG | BID | |||||||
| 1213476112 | 12134761 | 5 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 200 MG, BID | U | 0 | 200 | MG | BID | ||||||
| 1213476112 | 12134761 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 1213476112 | 12134761 | 7 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 1213476112 | 12134761 | 8 | C | OXYGEN. | OXYGEN | 1 | U | 0 | |||||||||||
| 1213476112 | 12134761 | 9 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | 18 MCG, QD | U | 0 | 18 | UG | QD | ||||||
| 1213476112 | 12134761 | 10 | C | ALBUTEROL HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 1213476112 | 12134761 | 11 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 5-325 MG, HALF TABLET Q4HRS | U | 0 | Q4H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1213476112 | 12134761 | 1 | Pulmonary arterial hypertension |
| 1213476112 | 12134761 | 2 | Product used for unknown indication |
| 1213476112 | 12134761 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1213476112 | 12134761 | OT |
| 1213476112 | 12134761 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1213476112 | 12134761 | Abdominal discomfort | |
| 1213476112 | 12134761 | Abdominal pain upper | |
| 1213476112 | 12134761 | Anaemia | |
| 1213476112 | 12134761 | Chills | |
| 1213476112 | 12134761 | Condition aggravated | |
| 1213476112 | 12134761 | Dehydration | |
| 1213476112 | 12134761 | Diarrhoea | |
| 1213476112 | 12134761 | Dyspnoea exertional | |
| 1213476112 | 12134761 | Epistaxis | |
| 1213476112 | 12134761 | Fungal oesophagitis | |
| 1213476112 | 12134761 | Fungal skin infection | |
| 1213476112 | 12134761 | Haemorrhage | |
| 1213476112 | 12134761 | Headache | |
| 1213476112 | 12134761 | Hypovolaemia | |
| 1213476112 | 12134761 | Influenza like illness | |
| 1213476112 | 12134761 | Loss of consciousness | |
| 1213476112 | 12134761 | Malaise | |
| 1213476112 | 12134761 | Nasal congestion | |
| 1213476112 | 12134761 | Nasal operation | |
| 1213476112 | 12134761 | Nausea | |
| 1213476112 | 12134761 | Oxygen saturation decreased | |
| 1213476112 | 12134761 | Pain in extremity | |
| 1213476112 | 12134761 | Pain in jaw | |
| 1213476112 | 12134761 | Proctalgia | |
| 1213476112 | 12134761 | Pulmonary hypertension | |
| 1213476112 | 12134761 | Pulmonary oedema | |
| 1213476112 | 12134761 | Syncope | |
| 1213476112 | 12134761 | Therapy non-responder | |
| 1213476112 | 12134761 | Toxicity to various agents | |
| 1213476112 | 12134761 | Vomiting | |
| 1213476112 | 12134761 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 1213476112 | 12134761 | 1 | 20160122 | 0 | ||
| 1213476112 | 12134761 | 2 | 2014 | 20160623 | 0 | |
| 1213476112 | 12134761 | 3 | 20140212 | 0 | ||
| 1213476112 | 12134761 | 4 | 2013 | 0 | ||
| 1213476112 | 12134761 | 5 | 2013 | 0 | ||
| 1213476112 | 12134761 | 7 | 2012 | 0 | ||
| 1213476112 | 12134761 | 9 | 2014 | 0 | ||
| 1213476112 | 12134761 | 11 | 201606 | 0 |