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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127086513 | 12708651 | 3 | F | 20151112 | 20160829 | 20160901 | 20160907 | EXP | PHJP2015JP020924 | NOVARTIS | 29.00 | YR | M | Y | 0.00000 | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127086513 | 12708651 | 1 | PS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, QD | 103764 | 20 | MG | SOLUTION FOR INJECTION | QD | ||||||
| 127086513 | 12708651 | 2 | SS | SIMULECT | BASILIXIMAB | 1 | 103764 | SOLUTION FOR INJECTION | |||||||||||
| 127086513 | 12708651 | 3 | SS | CEFAZOLIN | CEFAZOLIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 4 | SS | FENTANYL. | FENTANYL | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 5 | SS | REMIFENTANIL | REMIFENTANIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 6 | SS | REMIFENTANIL | REMIFENTANIL | 1 | U | 0 | |||||||||||
| 127086513 | 12708651 | 7 | SS | PROPOFOL. | PROPOFOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 8 | SS | ROCURONIUM BROMIDE. | ROCURONIUM BROMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 9 | SS | DESFLURANE. | DESFLURANE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127086513 | 12708651 | 10 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 2 G, QD | 0 | 2 | G | CAPSULE | QD | ||||||
| 127086513 | 12708651 | 11 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | CAPSULE | |||||||||||
| 127086513 | 12708651 | 12 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 24 MG, QD | U | 0 | 24 | MG | QD | ||||||
| 127086513 | 12708651 | 13 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | U | 0 | |||||||||||
| 127086513 | 12708651 | 14 | C | GRACEPTOR | TACROLIMUS | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | CAPSULE | |||||||
| 127086513 | 12708651 | 15 | C | MEDROL | METHYLPREDNISOLONE | 1 | Oral | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127086513 | 12708651 | 1 | Renal transplant |
| 127086513 | 12708651 | 2 | Prophylaxis against transplant rejection |
| 127086513 | 12708651 | 3 | Product used for unknown indication |
| 127086513 | 12708651 | 4 | Induction of anaesthesia |
| 127086513 | 12708651 | 5 | Induction of anaesthesia |
| 127086513 | 12708651 | 6 | Maintenance of anaesthesia |
| 127086513 | 12708651 | 7 | Induction of anaesthesia |
| 127086513 | 12708651 | 8 | Induction of anaesthesia |
| 127086513 | 12708651 | 9 | Maintenance of anaesthesia |
| 127086513 | 12708651 | 10 | Renal transplant |
| 127086513 | 12708651 | 11 | Prophylaxis against transplant rejection |
| 127086513 | 12708651 | 12 | Renal transplant |
| 127086513 | 12708651 | 13 | Prophylaxis against transplant rejection |
| 127086513 | 12708651 | 14 | Product used for unknown indication |
| 127086513 | 12708651 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127086513 | 12708651 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127086513 | 12708651 | Anaphylactic shock | |
| 127086513 | 12708651 | Blood pressure decreased | |
| 127086513 | 12708651 | Erythema | |
| 127086513 | 12708651 | Flushing | |
| 127086513 | 12708651 | Heart rate increased | |
| 127086513 | 12708651 | Pyrexia | |
| 127086513 | 12708651 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 127086513 | 12708651 | 1 | 20151112 | 0 | ||
| 127086513 | 12708651 | 10 | 20151105 | 0 | ||
| 127086513 | 12708651 | 14 | 20151105 | 0 | ||
| 127086513 | 12708651 | 15 | 20151105 | 0 |