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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124754493 | 12475449 | 3 | F | 20160523 | 20160907 | 20160617 | 20160912 | EXP | PHJP2016JP015151 | NOVARTIS | 68.07 | YR | F | Y | 53.35000 | KG | 20160912 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124754493 | 12475449 | 1 | PS | NEORAL | CYCLOSPORINE | 1 | Oral | 75 MG, BID (150 MG DAILY) | 1880 | MG | 50715 | 75 | MG | CAPSULE | BID | ||||
| 124754493 | 12475449 | 2 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 190 MG, QD | 1880 | MG | 50715 | 190 | MG | CAPSULE | QD | ||||
| 124754493 | 12475449 | 3 | SS | SANDIMMUN INFUSION | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 190 MG, QD | 0 | 190 | MG | SOLUTION FOR INFUSION | QD | ||||||
| 124754493 | 12475449 | 4 | SS | SANDIMMUN INFUSION | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 100 MG, QD | 0 | 100 | MG | SOLUTION FOR INFUSION | QD | ||||||
| 124754493 | 12475449 | 5 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 2.5 MG, QD | 0 | 2.5 | MG | TABLET | QD | ||||||
| 124754493 | 12475449 | 6 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 1000 MG, QD | 3000 | MG | 0 | 1000 | MG | INJECTION | QD | ||||
| 124754493 | 12475449 | 7 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 1000 MG, QD | 3000 | MG | 0 | 1000 | MG | INJECTION | QD | ||||
| 124754493 | 12475449 | 8 | C | TAKEPRON | LANSOPRAZOLE | 1 | Intravenous (not otherwise specified) | 30 MG, QD | 90 | MG | 0 | 30 | MG | INJECTION | QD | ||||
| 124754493 | 12475449 | 9 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 1 DF, QD | 5 | DF | 0 | 1 | DF | TABLET | QD | ||||
| 124754493 | 12475449 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 25 MG, BID | 250 | MG | 0 | 25 | MG | TABLET | BID | ||||
| 124754493 | 12475449 | 11 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 25 MG, BID | 250 | MG | 0 | 25 | MG | TABLET | BID | ||||
| 124754493 | 12475449 | 12 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 30 MG, QD | 60 | MG | 0 | 30 | MG | TABLET | QD | ||||
| 124754493 | 12475449 | 13 | C | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 500 MG, QD | 500 | MG | 0 | 500 | MG | INJECTION | QD | ||||
| 124754493 | 12475449 | 14 | C | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | 500 | MG | 0 | INJECTION | |||||||||
| 124754493 | 12475449 | 15 | C | VENOGLOBULIN IH | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 20 G, QD | 0 | 20 | G | INJECTION | QD | ||||||
| 124754493 | 12475449 | 16 | C | VENOGLOBULIN IH | HUMAN IMMUNOGLOBULIN G | 1 | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124754493 | 12475449 | 1 | Interstitial lung disease |
| 124754493 | 12475449 | 2 | Polymyositis |
| 124754493 | 12475449 | 3 | Interstitial lung disease |
| 124754493 | 12475449 | 4 | Polymyositis |
| 124754493 | 12475449 | 5 | Hypercholesterolaemia |
| 124754493 | 12475449 | 6 | Polymyositis |
| 124754493 | 12475449 | 8 | Product used for unknown indication |
| 124754493 | 12475449 | 9 | Product used for unknown indication |
| 124754493 | 12475449 | 10 | Interstitial lung disease |
| 124754493 | 12475449 | 11 | Polymyositis |
| 124754493 | 12475449 | 12 | Product used for unknown indication |
| 124754493 | 12475449 | 13 | Interstitial lung disease |
| 124754493 | 12475449 | 14 | Polymyositis |
| 124754493 | 12475449 | 15 | Polymyositis |
| 124754493 | 12475449 | 16 | Interstitial lung disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124754493 | 12475449 | OT |
| 124754493 | 12475449 | DE |
| 124754493 | 12475449 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124754493 | 12475449 | Blood lactate dehydrogenase increased | |
| 124754493 | 12475449 | Drug ineffective for unapproved indication | |
| 124754493 | 12475449 | Dyspnoea | |
| 124754493 | 12475449 | Loss of consciousness | |
| 124754493 | 12475449 | Lymphocyte count decreased | |
| 124754493 | 12475449 | Monocyte count decreased | |
| 124754493 | 12475449 | Oral administration complication | |
| 124754493 | 12475449 | Product use issue | |
| 124754493 | 12475449 | Respiratory disorder |
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 |
|---|---|---|---|---|---|---|
| 124754493 | 12475449 | 1 | 20160523 | 20160601 | 0 | |
| 124754493 | 12475449 | 2 | 20160602 | 20160603 | 0 | |
| 124754493 | 12475449 | 3 | 20160604 | 20160606 | 0 | |
| 124754493 | 12475449 | 4 | 20160607 | 20160609 | 0 | |
| 124754493 | 12475449 | 5 | 20160520 | 0 | ||
| 124754493 | 12475449 | 6 | 20160520 | 20160522 | 0 | |
| 124754493 | 12475449 | 7 | 20160528 | 20160530 | 0 | |
| 124754493 | 12475449 | 8 | 20160520 | 20160522 | 0 | |
| 124754493 | 12475449 | 9 | 20160520 | 20160524 | 0 | |
| 124754493 | 12475449 | 10 | 20160523 | 20160527 | 0 | |
| 124754493 | 12475449 | 11 | 20160531 | 20160602 | 0 | |
| 124754493 | 12475449 | 12 | 20160523 | 20160524 | 0 | |
| 124754493 | 12475449 | 13 | 20160531 | 20160531 | 0 | |
| 124754493 | 12475449 | 15 | 20160603 | 20160607 | 0 |