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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125801422 | 12580142 | 2 | F | 2014 | 20160727 | 20160721 | 20160811 | EXP | US-WEST-WARD PHARMACEUTICALS CORP.-US-H14001-16-01338 | WESTWARD | 53.30 | YR | M | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125801422 | 12580142 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | Y | 65413 | 1000 | MG | Q8H | |||||||
| 125801422 | 12580142 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | Y | 65413 | ||||||||||
| 125801422 | 12580142 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 87342 | 40 | MG | BID | ||||||||
| 125801422 | 12580142 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 84122 | 10 | MG | BID | ||||||||
| 125801422 | 12580142 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 84122 | |||||||||||
| 125801422 | 12580142 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 84122 | 30 | MG | |||||||||
| 125801422 | 12580142 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 84122 | 25 | MG | |||||||||
| 125801422 | 12580142 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 84122 | 20 | MG | |||||||||
| 125801422 | 12580142 | 9 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Oral | 0 | 125 | MG | Q12H | ||||||||
| 125801422 | 12580142 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | |||||||||||
| 125801422 | 12580142 | 11 | C | SIROLIMUS. | SIROLIMUS | 1 | Unknown | 0 | |||||||||||
| 125801422 | 12580142 | 12 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | Oral | 0 | 10 | MG | Q6H | ||||||||
| 125801422 | 12580142 | 13 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 0 | 400 | MG | Q12H | ||||||||
| 125801422 | 12580142 | 14 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | QD | ||||||||
| 125801422 | 12580142 | 15 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | |||||||||
| 125801422 | 12580142 | 16 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 0 | 200 | MG | Q12H | ||||||||
| 125801422 | 12580142 | 17 | C | POSACONAZOLE | POSACONAZOLE | 1 | Oral | 0 | 300 | MG | QD | ||||||||
| 125801422 | 12580142 | 18 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 5 | DF | QD | ||||||||
| 125801422 | 12580142 | 19 | C | MULTIVITAMIN | VITAMINS | 1 | Oral | 0 | 1 | DF | QD | ||||||||
| 125801422 | 12580142 | 20 | C | PENTAMIDINE | PENTAMIDINE | 1 | Respiratory (inhalation) | 0 | |||||||||||
| 125801422 | 12580142 | 21 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 1 | DF | QD | ||||||||
| 125801422 | 12580142 | 22 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 0 | 1 | DF | QD | ||||||||
| 125801422 | 12580142 | 23 | C | MAGNESIUM AMINO ACIDS CHELATE | 2 | Oral | 0 | ||||||||||||
| 125801422 | 12580142 | 24 | C | MAGNESIUM AMINO ACIDS CHELATE | 2 | Oral | 0 | 2 | DF | QD | |||||||||
| 125801422 | 12580142 | 25 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 0 | |||||||||||
| 125801422 | 12580142 | 26 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125801422 | 12580142 | 1 | Prophylaxis against graft versus host disease |
| 125801422 | 12580142 | 3 | Graft versus host disease |
| 125801422 | 12580142 | 4 | Graft versus host disease |
| 125801422 | 12580142 | 9 | Prophylaxis against graft versus host disease |
| 125801422 | 12580142 | 10 | Prophylaxis against graft versus host disease |
| 125801422 | 12580142 | 11 | Prophylaxis against graft versus host disease |
| 125801422 | 12580142 | 12 | Nausea |
| 125801422 | 12580142 | 13 | Antiviral treatment |
| 125801422 | 12580142 | 14 | Antacid therapy |
| 125801422 | 12580142 | 15 | Diarrhoea |
| 125801422 | 12580142 | 16 | Antifungal treatment |
| 125801422 | 12580142 | 17 | Antifungal treatment |
| 125801422 | 12580142 | 18 | Supplementation therapy |
| 125801422 | 12580142 | 19 | Supplementation therapy |
| 125801422 | 12580142 | 20 | Infection prophylaxis |
| 125801422 | 12580142 | 21 | Supplementation therapy |
| 125801422 | 12580142 | 22 | Antifungal treatment |
| 125801422 | 12580142 | 23 | Supplementation therapy |
| 125801422 | 12580142 | 25 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125801422 | 12580142 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125801422 | 12580142 | Acute sinusitis | |
| 125801422 | 12580142 | Bone marrow failure | |
| 125801422 | 12580142 | Condition aggravated | |
| 125801422 | 12580142 | Dizziness | |
| 125801422 | 12580142 | Drug level increased | |
| 125801422 | 12580142 | Hyperglycaemia | |
| 125801422 | 12580142 | Hypertension | |
| 125801422 | 12580142 | Insomnia | |
| 125801422 | 12580142 | Leukocytosis | |
| 125801422 | 12580142 | Neurotoxicity | |
| 125801422 | 12580142 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 125801422 | 12580142 | 1 | 20140612 | 201410 | 0 | |
| 125801422 | 12580142 | 2 | 20141002 | 20141118 | 0 | |
| 125801422 | 12580142 | 3 | 20140630 | 0 | ||
| 125801422 | 12580142 | 4 | 20140630 | 20140710 | 0 | |
| 125801422 | 12580142 | 5 | 20140710 | 20140815 | 0 | |
| 125801422 | 12580142 | 6 | 20140815 | 2014 | 0 | |
| 125801422 | 12580142 | 7 | 2014 | 2014 | 0 | |
| 125801422 | 12580142 | 8 | 2014 | 2014 | 0 | |
| 125801422 | 12580142 | 10 | 20140612 | 0 | ||
| 125801422 | 12580142 | 11 | 20140627 | 0 | ||
| 125801422 | 12580142 | 16 | 20140705 | 0 | ||
| 125801422 | 12580142 | 17 | 20140705 | 0 | ||
| 125801422 | 12580142 | 20 | 2014 | 0 | ||
| 125801422 | 12580142 | 21 | 2014 | 0 | ||
| 125801422 | 12580142 | 22 | 2014 | 0 | ||
| 125801422 | 12580142 | 23 | 2014 | 20141014 | 0 | |
| 125801422 | 12580142 | 24 | 20141014 | 0 | ||
| 125801422 | 12580142 | 25 | 20140615 | 20140622 | 0 | |
| 125801422 | 12580142 | 26 | 20140615 | 20140622 | 0 |