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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 972807916 | 9728079 | 16 | F | 20130628 | 20160802 | 20131204 | 20160810 | EXP | PHHY2013US136284 | SANDOZ | 60.92 | YR | F | Y | 78.00000 | KG | 20160810 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 972807916 | 9728079 | 1 | SS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, BID (DAY1) | 240 | MG | 0 | 20 | MG | BID | |||||
| 972807916 | 9728079 | 2 | SS | SIMULECT | BASILIXIMAB | 1 | Intravenous (not otherwise specified) | 20 MG, BID (DAY 4) | 240 | MG | 0 | 20 | MG | BID | |||||
| 972807916 | 9728079 | 3 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1000 MG, BID | 297420 | MG | Y | 65379 | 1000 | MG | BID | ||||
| 972807916 | 9728079 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 750 MG, BID | 297420 | MG | Y | 65379 | 750 | MG | BID | ||||
| 972807916 | 9728079 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1080 MG, QD | 297420 | MG | Y | 65379 | 1080 | MG | QD | ||||
| 972807916 | 9728079 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG IN AM AND 2 MG IN AFTERNOON | 0 | CAPSULE | |||||||||
| 972807916 | 9728079 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, BID | 0 | 3 | MG | CAPSULE | BID | ||||||
| 972807916 | 9728079 | 8 | SS | NIFEDIPINE. | NIFEDIPINE | 1 | Oral | 60 MG, BID | Y | 0 | 60 | MG | BID | ||||||
| 972807916 | 9728079 | 9 | SS | NIFEDIPINE. | NIFEDIPINE | 1 | Unknown | 30 MG, BID | Y | 0 | 30 | MG | BID | ||||||
| 972807916 | 9728079 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 972807916 | 9728079 | 11 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 972807916 | 9728079 | 12 | C | TENEX | GUANFACINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 972807916 | 9728079 | 13 | C | AMBISOME | AMPHOTERICIN B | 1 | Unknown | UNK | Y | 0 | INJECTION | ||||||||
| 972807916 | 9728079 | 14 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 15 | C | CATAPRES | CLONIDINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 16 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | UNK | 0 | ||||||||||
| 972807916 | 9728079 | 17 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 972807916 | 9728079 | 18 | C | COREG | CARVEDILOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 19 | C | LYRICA | PREGABALIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 20 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | INJECTION | ||||||||
| 972807916 | 9728079 | 21 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 972807916 | 9728079 | 22 | C | REGELAN//METOCLOPRAMIDE | METOCLOPRAMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 23 | C | PEPCID | FAMOTIDINE | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | TABLET | ||||||
| 972807916 | 9728079 | 24 | C | FIBERCON | CALCIUM POLYCARBOPHIL | 1 | Unknown | UNK | U | 0 | TABLET | ||||||||
| 972807916 | 9728079 | 25 | C | DELTASONE | PREDNISONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 26 | C | HUMALOG | INSULIN LISPRO | 1 | Unknown | UNK | U | 0 | INJECTION | ||||||||
| 972807916 | 9728079 | 27 | C | GLUCOSE MONOHYDRATE | DEXTROSE MONOHYDRATE | 1 | Unknown | UNK | U | 0 | CHEWABLE TABLET | ||||||||
| 972807916 | 9728079 | 28 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 29 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 30 | C | EPHEDRA | EPHEDRA | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 31 | C | DIFLUCAN | FLUCONAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 32 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 40 MG, UNK | U | 0 | 40 | MG | TABLET | ||||||
| 972807916 | 9728079 | 33 | C | HYDRALAZINE HCL | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG | TABLET | ||||||
| 972807916 | 9728079 | 34 | C | RAMIRON | 2 | Unknown | UNK | U | 0 | ||||||||||
| 972807916 | 9728079 | 35 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 972807916 | 9728079 | 36 | C | DEXTROSE. | DEXTROSE | 1 | Unknown | UNK | U | 0 | INJECTION | ||||||||
| 972807916 | 9728079 | 37 | C | GLUCAGON. | GLUCAGON | 1 | Unknown | U | 0 | ||||||||||
| 972807916 | 9728079 | 38 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, UNK | U | 0 | 5 | MG | TABLET | ||||||
| 972807916 | 9728079 | 39 | C | CALCIUM +D /07511201/ | 2 | Unknown | 1000 MG, (800-1000 MG) | U | 0 | 1000 | MG | TABLET | |||||||
| 972807916 | 9728079 | 40 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 12.5 MG, UNK | U | 0 | 12.5 | MG | TABLET | ||||||
| 972807916 | 9728079 | 41 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | (5-325 MG), UNK | U | 0 | TABLET | ||||||||
| 972807916 | 9728079 | 42 | C | LEVEMIR | INSULIN DETEMIR | 1 | Unknown | U | 0 | SOLUTION FOR INFUSION | |||||||||
| 972807916 | 9728079 | 43 | C | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | 360 MG, UNK | U | 0 | 360 | MG | TABLET | ||||||
| 972807916 | 9728079 | 44 | C | NOVOLOG | INSULIN ASPART | 1 | Unknown | U | 0 | SOLUTION FOR INFUSION | |||||||||
| 972807916 | 9728079 | 45 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | 15 MG, UNK | U | 0 | 15 | MG | TABLET | ||||||
| 972807916 | 9728079 | 46 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 972807916 | 9728079 | 1 | Renal transplant |
| 972807916 | 9728079 | 3 | Renal transplant |
| 972807916 | 9728079 | 6 | Renal transplant |
| 972807916 | 9728079 | 8 | Hypertension |
| 972807916 | 9728079 | 10 | Renal transplant |
| 972807916 | 9728079 | 12 | Product used for unknown indication |
| 972807916 | 9728079 | 13 | Product used for unknown indication |
| 972807916 | 9728079 | 14 | Product used for unknown indication |
| 972807916 | 9728079 | 15 | Product used for unknown indication |
| 972807916 | 9728079 | 16 | Product used for unknown indication |
| 972807916 | 9728079 | 17 | Product used for unknown indication |
| 972807916 | 9728079 | 18 | Product used for unknown indication |
| 972807916 | 9728079 | 19 | Product used for unknown indication |
| 972807916 | 9728079 | 20 | Product used for unknown indication |
| 972807916 | 9728079 | 21 | Product used for unknown indication |
| 972807916 | 9728079 | 22 | Product used for unknown indication |
| 972807916 | 9728079 | 23 | Product used for unknown indication |
| 972807916 | 9728079 | 24 | Product used for unknown indication |
| 972807916 | 9728079 | 25 | Product used for unknown indication |
| 972807916 | 9728079 | 26 | Product used for unknown indication |
| 972807916 | 9728079 | 27 | Product used for unknown indication |
| 972807916 | 9728079 | 28 | Product used for unknown indication |
| 972807916 | 9728079 | 29 | Product used for unknown indication |
| 972807916 | 9728079 | 30 | Product used for unknown indication |
| 972807916 | 9728079 | 31 | Product used for unknown indication |
| 972807916 | 9728079 | 32 | Product used for unknown indication |
| 972807916 | 9728079 | 33 | Product used for unknown indication |
| 972807916 | 9728079 | 34 | Product used for unknown indication |
| 972807916 | 9728079 | 35 | Product used for unknown indication |
| 972807916 | 9728079 | 36 | Product used for unknown indication |
| 972807916 | 9728079 | 37 | Product used for unknown indication |
| 972807916 | 9728079 | 38 | Product used for unknown indication |
| 972807916 | 9728079 | 39 | Product used for unknown indication |
| 972807916 | 9728079 | 40 | Product used for unknown indication |
| 972807916 | 9728079 | 41 | Product used for unknown indication |
| 972807916 | 9728079 | 42 | Product used for unknown indication |
| 972807916 | 9728079 | 43 | Product used for unknown indication |
| 972807916 | 9728079 | 44 | Product used for unknown indication |
| 972807916 | 9728079 | 45 | Product used for unknown indication |
| 972807916 | 9728079 | 46 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 972807916 | 9728079 | HO |
| 972807916 | 9728079 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 972807916 | 9728079 | Acute kidney injury | |
| 972807916 | 9728079 | Cytomegalovirus infection | |
| 972807916 | 9728079 | Diabetes mellitus | |
| 972807916 | 9728079 | Diarrhoea | |
| 972807916 | 9728079 | Disseminated cryptococcosis | |
| 972807916 | 9728079 | Dysphagia | |
| 972807916 | 9728079 | Escherichia urinary tract infection | |
| 972807916 | 9728079 | Fatigue | |
| 972807916 | 9728079 | Fluid overload | |
| 972807916 | 9728079 | Haemoglobin decreased | |
| 972807916 | 9728079 | Hallucination, visual | |
| 972807916 | 9728079 | Hypotension | |
| 972807916 | 9728079 | Hypothermia | |
| 972807916 | 9728079 | Hypovolaemia | |
| 972807916 | 9728079 | Immunosuppression | |
| 972807916 | 9728079 | Nausea | |
| 972807916 | 9728079 | Neuralgia | |
| 972807916 | 9728079 | Neuropathy peripheral | |
| 972807916 | 9728079 | Pyrexia | |
| 972807916 | 9728079 | Urinary tract infection enterococcal | |
| 972807916 | 9728079 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 972807916 | 9728079 | 1 | 20130624 | 20130628 | 0 | |
| 972807916 | 9728079 | 2 | 20130628 | 20130628 | 0 | |
| 972807916 | 9728079 | 3 | 20130624 | 0 | ||
| 972807916 | 9728079 | 4 | 20130625 | 20130818 | 0 | |
| 972807916 | 9728079 | 5 | 20150120 | 20150806 | 0 | |
| 972807916 | 9728079 | 6 | 20140519 | 0 | ||
| 972807916 | 9728079 | 7 | 20150119 | 0 | ||
| 972807916 | 9728079 | 8 | 20130624 | 0 | ||
| 972807916 | 9728079 | 10 | 20130624 | 0 | ||
| 972807916 | 9728079 | 11 | 20130701 | 0 | ||
| 972807916 | 9728079 | 12 | 20130627 | 0 | ||
| 972807916 | 9728079 | 13 | 20150813 | 20150821 | 0 | |
| 972807916 | 9728079 | 16 | 20141201 | 0 |