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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125729814 | 12572981 | 4 | F | 201608 | 20160906 | 20160720 | 20160908 | EXP | US-GILEAD-2016-0221502 | GILEAD | 35.00 | YR | A | F | Y | 55.78000 | KG | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125729814 | 12572981 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1509427A | 22081 | 10 | MG | TABLET | QD | |||||
| 125729814 | 12572981 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.073 UG/KG, UNK | U | 2100701 | 0 | .073 | UG/KG | ||||||
| 125729814 | 12572981 | 3 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 6 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 7 | C | SARNA (CAMPHOR (NATURAL)MENTHOL) | CAMPHOR (NATURAL)MENTHOL | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 8 | C | KEFLEX | CEPHALEXIN | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 9 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 10 | C | DIGOX /00017701/ | 2 | 0 | |||||||||||||
| 125729814 | 12572981 | 11 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 12 | C | IRON /00023503/ | IRON | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 13 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 14 | C | NEURONTIN | GABAPENTIN | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 15 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 16 | C | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 17 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 18 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 19 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 20 | C | ALDACTONE | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 21 | C | CIALIS | TADALAFIL | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 22 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125729814 | 12572981 | 23 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125729814 | 12572981 | 1 | Pulmonary hypertension |
| 125729814 | 12572981 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125729814 | 12572981 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125729814 | 12572981 | Infusion site infection | |
| 125729814 | 12572981 | Infusion site pain | |
| 125729814 | 12572981 | Infusion site rash | |
| 125729814 | 12572981 | Infusion site swelling | |
| 125729814 | 12572981 | Infusion site vesicles | |
| 125729814 | 12572981 | Skin discolouration |
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 |
|---|---|---|---|---|---|---|
| 125729814 | 12572981 | 1 | 20141215 | 0 | ||
| 125729814 | 12572981 | 2 | 20150123 | 0 |