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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124177394 | 12417739 | 4 | F | 201503 | 20160905 | 20160530 | 20160909 | EXP | PHJP2016JP014035 | NOVARTIS | 77.26 | YR | F | Y | 39.00000 | KG | 20160909 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124177394 | 12417739 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 150 MG, QD | 50715 | 150 | MG | CAPSULE | QD | ||||||
| 124177394 | 12417739 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | 50715 | CAPSULE | |||||||||||
| 124177394 | 12417739 | 3 | SS | SANDIMMUNE | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 124177394 | 12417739 | 4 | C | RINDERON V | BETAMETHASONE VALERATE | 1 | Oral | 4 MG, QD | 0 | 4 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 5 | C | RINDERON V | BETAMETHASONE VALERATE | 1 | 0 | TABLET | |||||||||||
| 124177394 | 12417739 | 6 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 7 | C | SELARA | EPLERENONE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 8 | C | GASCON | DIMETHICONE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 9 | C | MYSLEE | ZOLPIDEM TARTRATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 10 | C | FOSAMAC | ALENDRONATE SODIUM | 1 | Oral | 35 MG, QD | 0 | 35 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 11 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 124177394 | 12417739 | 12 | C | HALIZON | AMPHOTERICIN B | 1 | Oral | 400 MG, QD | 0 | 400 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 13 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 124177394 | 12417739 | 14 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 500 MG, QD | 0 | 500 | MG | INJECTION | QD | ||||||
| 124177394 | 12417739 | 15 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124177394 | 12417739 | 1 | Interstitial lung disease |
| 124177394 | 12417739 | 2 | Dermatomyositis |
| 124177394 | 12417739 | 3 | Product used for unknown indication |
| 124177394 | 12417739 | 4 | Interstitial lung disease |
| 124177394 | 12417739 | 5 | Dermatomyositis |
| 124177394 | 12417739 | 6 | Hypertension |
| 124177394 | 12417739 | 7 | Primary hyperaldosteronism |
| 124177394 | 12417739 | 8 | Product used for unknown indication |
| 124177394 | 12417739 | 9 | Product used for unknown indication |
| 124177394 | 12417739 | 10 | Product used for unknown indication |
| 124177394 | 12417739 | 11 | Product used for unknown indication |
| 124177394 | 12417739 | 12 | Product used for unknown indication |
| 124177394 | 12417739 | 13 | Product used for unknown indication |
| 124177394 | 12417739 | 14 | Interstitial lung disease |
| 124177394 | 12417739 | 15 | Dermatomyositis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124177394 | 12417739 | LT |
| 124177394 | 12417739 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124177394 | 12417739 | Blood urea increased | |
| 124177394 | 12417739 | Dermatomyositis | |
| 124177394 | 12417739 | Hepatitis fulminant | |
| 124177394 | 12417739 | Immunosuppressant drug level increased | |
| 124177394 | 12417739 | Interstitial lung disease | |
| 124177394 | 12417739 | Lymphocyte count decreased | |
| 124177394 | 12417739 | Product use issue | |
| 124177394 | 12417739 | Protein urine present | |
| 124177394 | 12417739 | Thrombotic thrombocytopenic purpura |
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 |
|---|---|---|---|---|---|---|
| 124177394 | 12417739 | 1 | 20150227 | 20150313 | 0 | |
| 124177394 | 12417739 | 4 | 20141219 | 0 | ||
| 124177394 | 12417739 | 9 | 20141222 | 0 | ||
| 124177394 | 12417739 | 10 | 20141226 | 0 | ||
| 124177394 | 12417739 | 11 | 20150103 | 20150114 | 0 | |
| 124177394 | 12417739 | 12 | 20140123 | 0 | ||
| 124177394 | 12417739 | 13 | 20141215 | 0 | ||
| 124177394 | 12417739 | 14 | 20150227 | 20150227 | 0 |