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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122401678 | 12240167 | 8 | F | 201603 | 20160823 | 20160405 | 20160829 | EXP | US-ACTELION-A-US2016-133186 | ACTELION | 60.00 | YR | A | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122401678 | 12240167 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM016A0301,UM016A0201,UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 122401678 | 12240167 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9X/DAY | MA02A59,MA00ZHE | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 122401678 | 12240167 | 3 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 2.5 MCG, 6X/DAY | MA02A59 | 21779 | 2.5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 122401678 | 12240167 | 4 | C | RIOCIGUAT | RIOCIGUAT | 1 | 2.5 MG, UNK | U | 0 | 2.5 | MG | ||||||||
| 122401678 | 12240167 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 122401678 | 12240167 | 6 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122401678 | 12240167 | 1 | Pulmonary hypertension |
| 122401678 | 12240167 | 2 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122401678 | 12240167 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122401678 | 12240167 | Abdominal distension | |
| 122401678 | 12240167 | Blood count abnormal | |
| 122401678 | 12240167 | Chest pain | |
| 122401678 | 12240167 | Cough | |
| 122401678 | 12240167 | Dizziness | |
| 122401678 | 12240167 | Dyspnoea exertional | |
| 122401678 | 12240167 | Exercise tolerance decreased | |
| 122401678 | 12240167 | Fatigue | |
| 122401678 | 12240167 | Fluid retention | |
| 122401678 | 12240167 | Gait disturbance | |
| 122401678 | 12240167 | Heart rate abnormal | |
| 122401678 | 12240167 | Hypotension | |
| 122401678 | 12240167 | Pain | |
| 122401678 | 12240167 | Palpitations | |
| 122401678 | 12240167 | Peripheral swelling | |
| 122401678 | 12240167 | Pneumonia | |
| 122401678 | 12240167 | Sickle cell anaemia | |
| 122401678 | 12240167 | Sickle cell anaemia with crisis | |
| 122401678 | 12240167 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 122401678 | 12240167 | 1 | 20160205 | 0 | ||
| 122401678 | 12240167 | 3 | 20080521 | 0 |