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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692481 | 12669248 | 1 | I | 2012 | 20160727 | 20160819 | 20160819 | EXP | BE-MLMSERVICE-20160721-0358575-1 | BE-ALKEM LABORATORIES LIMITED-BE-ALKEM-2016-00127 | ALKEM | 55.00 | YR | M | Y | 0.00000 | 20160819 | CN | GB | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692481 | 12669248 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNKNOWN | 91249 | |||||||||||
| 126692481 | 12669248 | 2 | I | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 500 MG, BID | 91249 | 500 | MG | Q12H | ||||||||
| 126692481 | 12669248 | 3 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | ||||||||||
| 126692481 | 12669248 | 4 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 0 | 4 | MG | QD | |||||||
| 126692481 | 12669248 | 5 | I | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 126692481 | 12669248 | 6 | I | TACROLIMUS. | TACROLIMUS | 1 | 0.5 MG, BID | 0 | .5 | MG | Q12H | ||||||||
| 126692481 | 12669248 | 7 | SS | POSACONAZOLE | POSACONAZOLE | 1 | 400 MG, BID | 0 | 400 | MG | Q12H | ||||||||
| 126692481 | 12669248 | 8 | I | FENTANYL. | FENTANYL | 1 | Transdermal | UNK | 0 | ||||||||||
| 126692481 | 12669248 | 9 | I | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | |||||||||||
| 126692481 | 12669248 | 10 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 126692481 | 12669248 | 11 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK, BID | 0 | Q12H | |||||||||
| 126692481 | 12669248 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, BID | 0 | 500 | MG | Q12H | |||||||
| 126692481 | 12669248 | 13 | C | CASPOFUNGIN | CASPOFUNGIN | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 126692481 | 12669248 | 14 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 500 MG, BID | 0 | 500 | MG | Q12H | |||||||
| 126692481 | 12669248 | 15 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | Q12H | |||||||
| 126692481 | 12669248 | 16 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | UNKNOWN | 0 | |||||||||||
| 126692481 | 12669248 | 17 | C | AMPHOTERICINE B, LIPOSOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 3 MG/KG, UNK | 0 | 3 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126692481 | 12669248 | 1 | Immunosuppression |
| 126692481 | 12669248 | 3 | Immunosuppression |
| 126692481 | 12669248 | 4 | Transplant rejection |
| 126692481 | 12669248 | 6 | Immunosuppression |
| 126692481 | 12669248 | 7 | Aspergilloma |
| 126692481 | 12669248 | 8 | Thoracic vertebral fracture |
| 126692481 | 12669248 | 10 | Aspergillus infection |
| 126692481 | 12669248 | 11 | Pseudomonas infection |
| 126692481 | 12669248 | 12 | Glucose tolerance impaired |
| 126692481 | 12669248 | 13 | Aspergillus infection |
| 126692481 | 12669248 | 14 | Sinusitis bacterial |
| 126692481 | 12669248 | 15 | Aspergilloma |
| 126692481 | 12669248 | 16 | Thoracic vertebral fracture |
| 126692481 | 12669248 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126692481 | 12669248 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126692481 | 12669248 | Abscess jaw | |
| 126692481 | 12669248 | Aspergilloma | |
| 126692481 | 12669248 | Aspergillus infection | |
| 126692481 | 12669248 | Cytomegalovirus viraemia | |
| 126692481 | 12669248 | Drug interaction | |
| 126692481 | 12669248 | Glucose tolerance impaired | |
| 126692481 | 12669248 | Hyponatraemia | |
| 126692481 | 12669248 | Inappropriate antidiuretic hormone secretion | |
| 126692481 | 12669248 | Nephropathy toxic | |
| 126692481 | 12669248 | Pneumonia pseudomonal | |
| 126692481 | 12669248 | Pseudomonas infection | |
| 126692481 | 12669248 | Sinusitis bacterial | |
| 126692481 | 12669248 | Stupor | |
| 126692481 | 12669248 | Thoracic vertebral fracture | |
| 126692481 | 12669248 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 126692481 | 12669248 | 5 | 2012 | 0 | ||
| 126692481 | 12669248 | 7 | 2012 | 2012 | 0 | |
| 126692481 | 12669248 | 8 | 2012 | 2012 | 0 | |
| 126692481 | 12669248 | 9 | 2012 | 2012 | 0 | |
| 126692481 | 12669248 | 12 | 2012 | 0 | ||
| 126692481 | 12669248 | 13 | 2012 | 0 | ||
| 126692481 | 12669248 | 14 | 2012 | 0 | ||
| 126692481 | 12669248 | 15 | 2012 | 0 | ||
| 126692481 | 12669248 | 16 | 2012 | 0 | ||
| 126692481 | 12669248 | 17 | 2012 | 0 |