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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126266846 | 12626684 | 6 | F | 20160106 | 20160823 | 20160805 | 20160826 | EXP | PHHY2016CN107245 | NOVARTIS | 51.12 | YR | M | Y | 67.50000 | KG | 20160826 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126266846 | 12626684 | 1 | PS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 720 MG, BID | 4320 | MG | Y | 50791 | 720 | MG | BID | ||||
| 126266846 | 12626684 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 540 MG, BID | 4320 | MG | Y | 50791 | 540 | MG | BID | ||||
| 126266846 | 12626684 | 3 | SS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 126266846 | 12626684 | 4 | SS | SIMULECT | BASILIXIMAB | 1 | 0 | ||||||||||||
| 126266846 | 12626684 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 7 MG, QD | 0 | 7 | MG | QD | |||||||
| 126266846 | 12626684 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126266846 | 12626684 | 7 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 660 MG, QD | 1360 | MG | Y | 0 | 660 | MG | QD | ||||
| 126266846 | 12626684 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intramuscular | 20 MG, QD | 1360 | MG | Y | 0 | 20 | MG | QD | ||||
| 126266846 | 12626684 | 9 | C | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | 30 MG, QD | Y | 0 | 30 | MG | QD | ||||||
| 126266846 | 12626684 | 10 | C | TIENAM | CILASTATIN SODIUMIMIPENEM | 1 | Intravenous (not otherwise specified) | 0.5 G, Q8H | Y | 0 | .5 | G | Q8H | ||||||
| 126266846 | 12626684 | 11 | C | TALCID | HYDROTALCITE | 1 | Oral | 1000 MG, QD | 0 | 1000 | MG | QD | |||||||
| 126266846 | 12626684 | 12 | C | ALPAX//ALPRAZOLAM | 2 | Oral | 0.4 UNK, QN | Y | 0 | TABLET | |||||||||
| 126266846 | 12626684 | 13 | C | DILTIAZEM HYDROCHLORIDE. | DILTIAZEM HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 0 | 30 | MG | TABLET | QD | ||||||
| 126266846 | 12626684 | 14 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 40 MG, QD | Y | 0 | 40 | MG | ENTERIC-FILM-COATED TABLET | QD | |||||
| 126266846 | 12626684 | 15 | C | AMIKACIN | AMIKACIN | 1 | Intravenous (not otherwise specified) | 400 MG, PRN | Y | 0 | 400 | MG | INJECTION | ||||||
| 126266846 | 12626684 | 16 | C | MANNITOL. | MANNITOL | 1 | Unknown | 125 MG, QD | Y | 0 | 125 | MG | QD | ||||||
| 126266846 | 12626684 | 17 | C | SUCROSE | SUCROSE | 1 | Oral | 750 MG, UNK | Y | 0 | 750 | MG | CHEWABLE TABLET | ||||||
| 126266846 | 12626684 | 18 | C | DEXA//DEXAMETHASONE | 2 | Intravenous (not otherwise specified) | 10 MG, QD | Y | 0 | 10 | MG | INJECTION | QD | ||||||
| 126266846 | 12626684 | 19 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 5 MG, QD | Y | 0 | 5 | MG | QD | ||||||
| 126266846 | 12626684 | 20 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 80 MG, QD | Y | 0 | 80 | MG | INJECTION | QD | |||||
| 126266846 | 12626684 | 21 | C | CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 1 | Intravenous (not otherwise specified) | 50 MG, QD | Y | 0 | 50 | MG | INJECTION | QD | |||||
| 126266846 | 12626684 | 22 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Intravenous (not otherwise specified) | 500 ML, QD | Y | 0 | 500 | ML | INJECTION | QD | |||||
| 126266846 | 12626684 | 23 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | QD | Y | 0 | 300 | ML | INJECTION | QD | |||||
| 126266846 | 12626684 | 24 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 12 ML, QD | Y | 0 | 12 | ML | INJECTION | QD | |||||
| 126266846 | 12626684 | 25 | C | HEPATITIS B IMMUNE GLOBULIN | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 400 IU, QD | Y | 0 | 400 | IU | INJECTION | QD | |||||
| 126266846 | 12626684 | 26 | C | INSULIN | INSULIN NOS | 1 | Intravenous (not otherwise specified) | 18 IU, QD | Y | 0 | 18 | IU | INJECTION | QD | |||||
| 126266846 | 12626684 | 27 | C | MAGNESII SULFAS | 2 | Intravenous (not otherwise specified) | 408 ML, QD | Y | 0 | 408 | ML | INJECTION | QD | ||||||
| 126266846 | 12626684 | 28 | C | ASCORBIC ACID W/CALCIUM GLUCONATE/C/00321301/ | 2 | Intravenous (not otherwise specified) | 3 G, QD | 9 | G | Y | 0 | 3 | G | INJECTION | QD | ||||
| 126266846 | 12626684 | 29 | C | AMPHOTERICINE B, LIPOSOME | AMPHOTERICIN B | 1 | Unknown | 10 MG, QD | 30 | MG | Y | 0 | 10 | MG | INJECTION | QD | |||
| 126266846 | 12626684 | 30 | C | PMS-PROMETHAZINE | 2 | Oral | 2 DF, QD | 6 | DF | Y | 0 | 2 | DF | TABLET | QD | ||||
| 126266846 | 12626684 | 31 | C | GLUCOS | 2 | Intravenous (not otherwise specified) | 3000 ML, QD | 3000 | ML | Y | 0 | 3000 | ML | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126266846 | 12626684 | 1 | Renal transplant |
| 126266846 | 12626684 | 2 | Prophylaxis against transplant rejection |
| 126266846 | 12626684 | 3 | Renal transplant |
| 126266846 | 12626684 | 4 | Prophylaxis against transplant rejection |
| 126266846 | 12626684 | 5 | Immunosuppressant drug therapy |
| 126266846 | 12626684 | 6 | Immunosuppressant drug therapy |
| 126266846 | 12626684 | 7 | Product used for unknown indication |
| 126266846 | 12626684 | 9 | Product used for unknown indication |
| 126266846 | 12626684 | 10 | Infection prophylaxis |
| 126266846 | 12626684 | 11 | Antacid therapy |
| 126266846 | 12626684 | 12 | Sedation |
| 126266846 | 12626684 | 13 | Product used for unknown indication |
| 126266846 | 12626684 | 14 | Gastritis prophylaxis |
| 126266846 | 12626684 | 15 | Prophylaxis |
| 126266846 | 12626684 | 16 | Prophylaxis |
| 126266846 | 12626684 | 17 | Gastritis prophylaxis |
| 126266846 | 12626684 | 18 | Prophylaxis |
| 126266846 | 12626684 | 19 | Sedation |
| 126266846 | 12626684 | 20 | Prophylaxis |
| 126266846 | 12626684 | 21 | Infection prophylaxis |
| 126266846 | 12626684 | 22 | Electrolyte substitution therapy |
| 126266846 | 12626684 | 23 | Fluid replacement |
| 126266846 | 12626684 | 24 | Electrolyte substitution therapy |
| 126266846 | 12626684 | 25 | Antiviral prophylaxis |
| 126266846 | 12626684 | 26 | Electrolyte substitution therapy |
| 126266846 | 12626684 | 27 | Electrolyte substitution therapy |
| 126266846 | 12626684 | 28 | Nutritional supplementation |
| 126266846 | 12626684 | 29 | Infection prophylaxis |
| 126266846 | 12626684 | 30 | Sedation |
| 126266846 | 12626684 | 31 | Electrolyte substitution therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126266846 | 12626684 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126266846 | 12626684 | Anxiety | |
| 126266846 | 12626684 | Defiant behaviour | |
| 126266846 | 12626684 | Delirium | |
| 126266846 | 12626684 | Hepatic steatosis | |
| 126266846 | 12626684 | Schizophrenia |
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 |
|---|---|---|---|---|---|---|
| 126266846 | 12626684 | 1 | 20160104 | 20160107 | 0 | |
| 126266846 | 12626684 | 2 | 20160108 | 20160118 | 0 | |
| 126266846 | 12626684 | 3 | 20160107 | 20160107 | 0 | |
| 126266846 | 12626684 | 5 | 20160104 | 0 | ||
| 126266846 | 12626684 | 7 | 20160103 | 20160104 | 0 | |
| 126266846 | 12626684 | 8 | 20160104 | 20160105 | 0 | |
| 126266846 | 12626684 | 9 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 10 | 20160103 | 20160107 | 0 | |
| 126266846 | 12626684 | 11 | 20160104 | 0 | ||
| 126266846 | 12626684 | 12 | 20160104 | 20160118 | 0 | |
| 126266846 | 12626684 | 13 | 20160104 | 0 | ||
| 126266846 | 12626684 | 14 | 20160104 | 20160115 | 0 | |
| 126266846 | 12626684 | 15 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 16 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 17 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 18 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 19 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 20 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 21 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 22 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 23 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 24 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 25 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 26 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 27 | 20160103 | 20160103 | 0 | |
| 126266846 | 12626684 | 28 | 20160104 | 20160107 | 0 | |
| 126266846 | 12626684 | 29 | 20160104 | 20160111 | 0 | |
| 126266846 | 12626684 | 30 | 20160104 | 20160118 | 0 | |
| 126266846 | 12626684 | 31 | 20160103 | 20160103 | 0 |