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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125355252 | 12535525 | 2 | F | 201602 | 20160715 | 20160707 | 20160719 | EXP | US-ROCHE-1787740 | ROCHE | 48.50 | YR | F | Y | 48.58000 | KG | 20160719 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125355252 | 12535525 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 500 | MG | BID | |||||||
| 125355252 | 12535525 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 2.5 MG/ML | Y | 926618 | 0 | .07 | UG/KG | ||||||
| 125355252 | 12535525 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | Y | 926618 | 0 | .065 | UG/KG | |||||||
| 125355252 | 12535525 | 4 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | U | 0 | 2.5 | MG | TID | |||||||
| 125355252 | 12535525 | 5 | C | COLCRYS | COLCHICINE | 1 | Oral | 0 | .6 | MG | QD | ||||||||
| 125355252 | 12535525 | 6 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 1-2 TABLETS EVERY 6 HOURS AS NEEDED | 0 | TABLET | |||||||||
| 125355252 | 12535525 | 7 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Oral | 0 | 500 | UG | TABLET | TIW | |||||||
| 125355252 | 12535525 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 125355252 | 12535525 | 9 | C | LETAIRIS | AMBRISENTAN | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 125355252 | 12535525 | 10 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 10 | MG | TABLET | ||||||||
| 125355252 | 12535525 | 11 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 0 | 25 | MG | BID | ||||||||
| 125355252 | 12535525 | 12 | C | HYDROXYCHLOROQUINE SULPHATE | HYDROXYCHLOROQUINE | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 125355252 | 12535525 | 13 | C | LASIX | FUROSEMIDE | 1 | Unknown | 0 | 40 | MG | BID | ||||||||
| 125355252 | 12535525 | 14 | C | K-DUR | POTASSIUM CHLORIDE | 1 | Unknown | 0 | BID | ||||||||||
| 125355252 | 12535525 | 15 | C | SILVADENE | SILVER SULFADIAZINE | 1 | Topical | 1 APPLICATION TWICE DAILY AS NEEDED | 0 | ||||||||||
| 125355252 | 12535525 | 16 | C | ASTELIN (UNITED STATES) | 2 | Unknown | 0 | 137 | UG | ||||||||||
| 125355252 | 12535525 | 17 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | ONCE AT BEDTIME | 0 | 300 | MG | ||||||||
| 125355252 | 12535525 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125355252 | 12535525 | 1 | Product used for unknown indication |
| 125355252 | 12535525 | 2 | Pulmonary hypertension |
| 125355252 | 12535525 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125355252 | 12535525 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125355252 | 12535525 | Cardiac failure high output | |
| 125355252 | 12535525 | Cataract | |
| 125355252 | 12535525 | Chronic kidney disease | |
| 125355252 | 12535525 | Diarrhoea | |
| 125355252 | 12535525 | Dyspnoea | |
| 125355252 | 12535525 | Fluid retention | |
| 125355252 | 12535525 | Hypokalaemia | |
| 125355252 | 12535525 | Iron deficiency anaemia | |
| 125355252 | 12535525 | Malaise | |
| 125355252 | 12535525 | Oedema peripheral | |
| 125355252 | 12535525 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125355252 | 12535525 | 1 | 20160512 | 0 | ||
| 125355252 | 12535525 | 2 | 20151006 | 0 | ||
| 125355252 | 12535525 | 3 | 20160225 | 0 |