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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121090976 | 12109097 | 6 | F | 20150520 | 20160905 | 20160224 | 20160912 | EXP | PHHO2015AU011881 | NOVARTIS | 64.64 | YR | M | Y | 63.00000 | KG | 20160912 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121090976 | 12109097 | 1 | PS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, BID | 169920 | MG | Y | 50791 | 720 | MG | BID | ||||
| 121090976 | 12109097 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 360 MG, BID | 169920 | MG | Y | 50791 | 360 | MG | BID | ||||
| 121090976 | 12109097 | 3 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 180 MG, BID | 169920 | MG | Y | 50791 | 180 | MG | BID | ||||
| 121090976 | 12109097 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 360 MG, BID | 169920 | MG | Y | 50791 | 360 | MG | BID | ||||
| 121090976 | 12109097 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1 G, BID | U | 0 | 1 | G | BID | ||||||
| 121090976 | 12109097 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1.5 MG, QD (1 MG MORNING AND 0.5 MG NIGHT) | U | 0 | 1.5 | MG | QD | ||||||
| 121090976 | 12109097 | 7 | SS | NO TREATMENT RECEIVED | UNSPECIFIED INGREDIENT | 1 | Unknown | NO TREATMENT | 0 | ||||||||||
| 121090976 | 12109097 | 8 | C | CALCITRIOL. | CALCITRIOL | 1 | Oral | 0.25 UG, QD (MANE) | U | 0 | .25 | UG | QD | ||||||
| 121090976 | 12109097 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 121090976 | 12109097 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 121090976 | 12109097 | 11 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, QD (MANE) | 0 | 25 | MG | QD | |||||||
| 121090976 | 12109097 | 12 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, QD (MANE) | 0 | 40 | MG | QD | |||||||
| 121090976 | 12109097 | 13 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 20 MG, QD (MANE) | 0 | 20 | MG | QD | |||||||
| 121090976 | 12109097 | 14 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG, BID | 11798.9063 | MG | Y | 0 | 50 | MG | BID | ||||
| 121090976 | 12109097 | 15 | C | ARANESP | DARBEPOETIN ALFA | 1 | Subcutaneous | 40 UG, QMO | 0 | 40 | UG | /month | |||||||
| 121090976 | 12109097 | 16 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | 40 MG, QD | Y | 0 | 40 | MG | QD | ||||||
| 121090976 | 12109097 | 17 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 121090976 | 12109097 | 18 | C | FRUSEMIDE | FUROSEMIDE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 121090976 | 12109097 | 19 | C | XALATAN | LATANOPROST | 1 | Ophthalmic | 1 DRP, QD IN BOTH EYES | 0 | 1 | GTT | EYE DROPS | QD | ||||||
| 121090976 | 12109097 | 20 | C | NOVORAPID | INSULIN ASPART | 1 | Subcutaneous | 32 U, (12 UNITS BREAKFAST + 20 UNITS LUNCH) | 0 | 32 | DF | ||||||||
| 121090976 | 12109097 | 21 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 121090976 | 12109097 | 22 | C | VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 1 | Unknown | 450 MG, QD | U | 0 | 450 | MG | QD | ||||||
| 121090976 | 12109097 | 23 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 1 DF, UNK | U | 0 | 1 | DF | |||||||
| 121090976 | 12109097 | 24 | C | CALTRATE | CALCIUM CARBONATE | 1 | Unknown | 600 MG, QD | U | 0 | 600 | MG | QD | ||||||
| 121090976 | 12109097 | 25 | C | NEBIVOLOL. | NEBIVOLOL | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 121090976 | 12109097 | 26 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 26 U, AT NIGHT | 0 | 26 | DF | ||||||||
| 121090976 | 12109097 | 27 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 121090976 | 12109097 | 28 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121090976 | 12109097 | 1 | Renal transplant |
| 121090976 | 12109097 | 5 | Renal transplant |
| 121090976 | 12109097 | 7 | Renal transplant |
| 121090976 | 12109097 | 8 | Vitamin D deficiency |
| 121090976 | 12109097 | 9 | Renal transplant |
| 121090976 | 12109097 | 11 | Diuretic therapy |
| 121090976 | 12109097 | 12 | Prophylaxis |
| 121090976 | 12109097 | 13 | Hypercholesterolaemia |
| 121090976 | 12109097 | 14 | Hypertension |
| 121090976 | 12109097 | 15 | Nephrogenic anaemia |
| 121090976 | 12109097 | 16 | Prophylaxis |
| 121090976 | 12109097 | 17 | Prophylaxis |
| 121090976 | 12109097 | 18 | Fluid overload |
| 121090976 | 12109097 | 19 | Glaucoma |
| 121090976 | 12109097 | 20 | Type 2 diabetes mellitus |
| 121090976 | 12109097 | 21 | Hypertension |
| 121090976 | 12109097 | 22 | Antiviral treatment |
| 121090976 | 12109097 | 23 | Antibiotic therapy |
| 121090976 | 12109097 | 24 | Mineral supplementation |
| 121090976 | 12109097 | 25 | Hypertension |
| 121090976 | 12109097 | 26 | Type 2 diabetes mellitus |
| 121090976 | 12109097 | 27 | Magnesium deficiency |
| 121090976 | 12109097 | 28 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121090976 | 12109097 | OT |
| 121090976 | 12109097 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121090976 | 12109097 | Cytomegalovirus colitis | |
| 121090976 | 12109097 | Diarrhoea | |
| 121090976 | 12109097 | Febrile neutropenia | |
| 121090976 | 12109097 | Hypomagnesaemia | |
| 121090976 | 12109097 | Lower respiratory tract infection | |
| 121090976 | 12109097 | Neutropenia |
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 |
|---|---|---|---|---|---|---|
| 121090976 | 12109097 | 1 | 20150123 | 20150701 | 0 | |
| 121090976 | 12109097 | 2 | 20150702 | 0 | ||
| 121090976 | 12109097 | 3 | 20150708 | 0 | ||
| 121090976 | 12109097 | 4 | 20150715 | 0 | ||
| 121090976 | 12109097 | 5 | 20150123 | 0 | ||
| 121090976 | 12109097 | 6 | 20160715 | 0 | ||
| 121090976 | 12109097 | 8 | 20160715 | 0 | ||
| 121090976 | 12109097 | 9 | 20150123 | 0 | ||
| 121090976 | 12109097 | 12 | 20150123 | 0 | ||
| 121090976 | 12109097 | 13 | 20150123 | 0 | ||
| 121090976 | 12109097 | 14 | 20150123 | 20150701 | 0 | |
| 121090976 | 12109097 | 15 | 20150709 | 0 | ||
| 121090976 | 12109097 | 16 | 20150702 | 20150711 | 0 | |
| 121090976 | 12109097 | 21 | 20160715 | 0 | ||
| 121090976 | 12109097 | 22 | 20160506 | 20160715 | 0 | |
| 121090976 | 12109097 | 23 | 20160715 | 0 | ||
| 121090976 | 12109097 | 24 | 20160715 | 0 | ||
| 121090976 | 12109097 | 25 | 20160715 | 0 | ||
| 121090976 | 12109097 | 28 | 20150123 | 0 |