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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126915431 | 12691543 | 1 | I | 20130410 | 20160826 | 20160826 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2013VAL000658 | VALIDUS | 0.00 | Y | 0.00000 | 20160826 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126915431 | 12691543 | 1 | PS | CALCITRIOL. | CALCITRIOL | 1 | Oral | 1 MG, 3 IN 1 WK | U | 21068 | 1 | MG | ORAL SOLUTION | ||||||
| 126915431 | 12691543 | 2 | C | CALCIUM GLUCONATE. | CALCIUM GLUCONATE | 1 | Intravenous (not otherwise specified) | 1500 MG, UNK | U | 0 | 1500 | MG | |||||||
| 126915431 | 12691543 | 3 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | Oral | 8000 IU, QD | U | 0 | 8000 | IU | |||||||
| 126915431 | 12691543 | 4 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | 2 ML, QD | U | 0 | 2 | ML | |||||||
| 126915431 | 12691543 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0.2 ML, QD | U | 0 | .2 | ML | |||||||
| 126915431 | 12691543 | 6 | C | CITRIC ACID | CITRIC ACID MONOHYDRATE | 1 | Topical | UNK | U | 0 | |||||||||
| 126915431 | 12691543 | 7 | C | ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | 1 | Oral | /5ML 200 MG | U | 0 | 200 | MG | |||||||
| 126915431 | 12691543 | 8 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | Oral | 25 ?G, 1 IN 1 D | U | 0 | 25 | UG | TABLET | ||||||
| 126915431 | 12691543 | 9 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 10 MG, 2 IN 1 D | U | 0 | 10 | MG | |||||||
| 126915431 | 12691543 | 10 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 5 MG, 4 IN 1 D | U | 0 | 5 | MG | SYRUP | ||||||
| 126915431 | 12691543 | 11 | C | EPOETIN ALFA | ERYTHROPOIETIN | 1 | 2000 UNITS/ML, QD | U | 0 | SOLUTION FOR INJECTION | |||||||||
| 126915431 | 12691543 | 12 | C | NYSTATIN. | NYSTATIN | 1 | Topical | 100000 UNITS/G, 4 IN 1 D | U | 0 | OINTMENT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126915431 | 12691543 | 1 | Chronic kidney disease-mineral and bone disorder |
| 126915431 | 12691543 | 2 | Product used for unknown indication |
| 126915431 | 12691543 | 3 | Product used for unknown indication |
| 126915431 | 12691543 | 4 | Product used for unknown indication |
| 126915431 | 12691543 | 5 | Product used for unknown indication |
| 126915431 | 12691543 | 6 | Product used for unknown indication |
| 126915431 | 12691543 | 7 | Product used for unknown indication |
| 126915431 | 12691543 | 8 | Product used for unknown indication |
| 126915431 | 12691543 | 9 | Product used for unknown indication |
| 126915431 | 12691543 | 10 | Product used for unknown indication |
| 126915431 | 12691543 | 11 | Product used for unknown indication |
| 126915431 | 12691543 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126915431 | 12691543 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126915431 | 12691543 | Cough | |
| 126915431 | 12691543 | Dehydration | |
| 126915431 | 12691543 | Gastroenteritis | |
| 126915431 | 12691543 | Hypotension | |
| 126915431 | 12691543 | Nausea | |
| 126915431 | 12691543 | Retching | |
| 126915431 | 12691543 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126915431 | 12691543 | 1 | 20120730 | 0 | ||
| 126915431 | 12691543 | 2 | 20121013 | 0 | ||
| 126915431 | 12691543 | 3 | 20130306 | 0 | ||
| 126915431 | 12691543 | 4 | 20120223 | 0 | ||
| 126915431 | 12691543 | 5 | 20120223 | 0 | ||
| 126915431 | 12691543 | 6 | 20121116 | 0 | ||
| 126915431 | 12691543 | 7 | 20121018 | 0 | ||
| 126915431 | 12691543 | 8 | 20130306 | 0 | ||
| 126915431 | 12691543 | 9 | 20120727 | 0 | ||
| 126915431 | 12691543 | 10 | 20121018 | 0 | ||
| 126915431 | 12691543 | 11 | 20120125 | 0 | ||
| 126915431 | 12691543 | 12 | 20121116 | 0 |