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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1169376813 | 11693768 | 13 | F | 20151026 | 20160831 | 20151103 | 20160913 | EXP | US-ACTELION PHARMACEUTICALS US, INC.-A-US2015-126541 | ACTELION | 51.00 | YR | A | F | Y | 56.78000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1169376813 | 11693768 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM017N0201;UM016A0201 | 204410 | 10 | MG | TABLET | QD | |||||
| 1169376813 | 11693768 | 2 | SS | OPSUMIT | MACITENTAN | 1 | 204410 | TABLET | |||||||||||
| 1169376813 | 11693768 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 35.5 NG/KG, PER MIN | U | U | V038,V380, V926 | 0 | /min | ||||||
| 1169376813 | 11693768 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 22 NG/KG, PER MIN | U | U | V380 | 0 | /min | ||||||
| 1169376813 | 11693768 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 1169376813 | 11693768 | 6 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 40 MG, UNK | U | 0 | 40 | MG | ||||||||
| 1169376813 | 11693768 | 7 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | 150 MG, BID | U | 0 | 150 | MG | BID | |||||||
| 1169376813 | 11693768 | 8 | C | VALIUM | DIAZEPAM | 1 | 5 MG, Q6HRS PRN | U | 0 | 5 | MG | QID | |||||||
| 1169376813 | 11693768 | 9 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 40 MG, TID | U | 0 | 40 | MG | TID | |||||||
| 1169376813 | 11693768 | 10 | C | NEURONTIN | GABAPENTIN | 1 | 100 MG, TID | U | 0 | 100 | MG | TID | |||||||
| 1169376813 | 11693768 | 11 | C | MULTIVITAMIN | VITAMINS | 1 | U | 0 | |||||||||||
| 1169376813 | 11693768 | 12 | C | PRAVASTATIN. | PRAVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 1169376813 | 11693768 | 13 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 1169376813 | 11693768 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1169376813 | 11693768 | 1 | Pulmonary hypertension |
| 1169376813 | 11693768 | 2 | Pulmonary hypertension |
| 1169376813 | 11693768 | 3 | Pulmonary hypertension |
| 1169376813 | 11693768 | 8 | Dizziness |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1169376813 | 11693768 | OT |
| 1169376813 | 11693768 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1169376813 | 11693768 | Catheter site discharge | |
| 1169376813 | 11693768 | Catheter site erythema | |
| 1169376813 | 11693768 | Catheter site swelling | |
| 1169376813 | 11693768 | Cerebral haemorrhage | |
| 1169376813 | 11693768 | Condition aggravated | |
| 1169376813 | 11693768 | Contusion | |
| 1169376813 | 11693768 | Cough | |
| 1169376813 | 11693768 | Device malfunction | |
| 1169376813 | 11693768 | Device related infection | |
| 1169376813 | 11693768 | Disorientation | |
| 1169376813 | 11693768 | Dizziness | |
| 1169376813 | 11693768 | Eye pain | |
| 1169376813 | 11693768 | Facial pain | |
| 1169376813 | 11693768 | Fall | |
| 1169376813 | 11693768 | Fluid overload | |
| 1169376813 | 11693768 | Headache | |
| 1169376813 | 11693768 | Hypoaesthesia | |
| 1169376813 | 11693768 | Hypotension | |
| 1169376813 | 11693768 | Muscular weakness | |
| 1169376813 | 11693768 | Nausea | |
| 1169376813 | 11693768 | Nervous system disorder | |
| 1169376813 | 11693768 | Ocular hyperaemia | |
| 1169376813 | 11693768 | Oedema | |
| 1169376813 | 11693768 | Pain in extremity | |
| 1169376813 | 11693768 | Presyncope | |
| 1169376813 | 11693768 | Pulmonary arterial hypertension | |
| 1169376813 | 11693768 | Right ventricular failure | |
| 1169376813 | 11693768 | Seizure | |
| 1169376813 | 11693768 | Subarachnoid haemorrhage | |
| 1169376813 | 11693768 | Subdural haematoma | |
| 1169376813 | 11693768 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 1169376813 | 11693768 | 1 | 20151022 | 0 | ||
| 1169376813 | 11693768 | 3 | 19990112 | 0 | ||
| 1169376813 | 11693768 | 6 | 2008 | 0 | ||
| 1169376813 | 11693768 | 7 | 2013 | 0 | ||
| 1169376813 | 11693768 | 12 | 201208 | 0 |