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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127042833 | 12704283 | 3 | F | 20160729 | 20160914 | 20160831 | 20160920 | EXP | FR-ASTELLAS-2016US033394 | ASTELLAS | 47.32 | YR | F | Y | 0.00000 | 20160920 | CN | US | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127042833 | 12704283 | 1 | PS | Advagraf | TACROLIMUS | 1 | Oral | UNK UNK, UNKNOWN FREQ. | D | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 127042833 | 12704283 | 2 | SS | Advagraf | TACROLIMUS | 1 | Oral | Y | 204096 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||||
| 127042833 | 12704283 | 3 | SS | Advagraf | TACROLIMUS | 1 | Oral | UNK UNK, UNKNOWN FREQ. | 204096 | MODIFIED-RELEASE CAPSULE, HARD | |||||||||
| 127042833 | 12704283 | 4 | SS | Atorvastatin | ATORVASTATIN | 1 | Oral | Y | 0 | 10 | MG | TABLET | QD | ||||||
| 127042833 | 12704283 | 5 | SS | XANAX | ALPRAZOLAM | 1 | Oral | UNK, UNKNOWN FREQ. | D | 0 | TABLET | ||||||||
| 127042833 | 12704283 | 6 | SS | XANAX | ALPRAZOLAM | 1 | Oral | INCREASED DOSE, UNKNOWN FREQ. | Y | 0 | TABLET | ||||||||
| 127042833 | 12704283 | 7 | SS | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | D | 0 | GASTRO-RESISTANT TABLET | ||||||||
| 127042833 | 12704283 | 8 | SS | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | Y | 0 | 40 | MG | GASTRO-RESISTANT TABLET | QD | ||||||
| 127042833 | 12704283 | 9 | SS | SEROPLEX | ESCITALOPRAM OXALATE | 1 | Oral | UNK, UNKNOWN FREQ. | D | 0 | FORMULATION UNKNOWN | ||||||||
| 127042833 | 12704283 | 10 | SS | SEROPLEX | ESCITALOPRAM OXALATE | 1 | Oral | INCREASED DOSE, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 127042833 | 12704283 | 11 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 127042833 | 12704283 | 12 | C | TRIATEC /00885601/ | RAMIPRIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 127042833 | 12704283 | 13 | C | KAYEXALATE | SODIUM POLYSTYRENE SULFONATE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 127042833 | 12704283 | 14 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127042833 | 12704283 | 1 | Prophylaxis against transplant rejection |
| 127042833 | 12704283 | 4 | Cardiovascular event prophylaxis |
| 127042833 | 12704283 | 5 | Anxiety |
| 127042833 | 12704283 | 7 | Gastrointestinal pain |
| 127042833 | 12704283 | 9 | Depression |
| 127042833 | 12704283 | 11 | Product used for unknown indication |
| 127042833 | 12704283 | 12 | Product used for unknown indication |
| 127042833 | 12704283 | 13 | Product used for unknown indication |
| 127042833 | 12704283 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127042833 | 12704283 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127042833 | 12704283 | Alanine aminotransferase increased | |
| 127042833 | 12704283 | Aspartate aminotransferase increased | |
| 127042833 | 12704283 | Blood alkaline phosphatase increased | |
| 127042833 | 12704283 | Cerebral ischaemia | |
| 127042833 | 12704283 | Gamma-glutamyltransferase increased | |
| 127042833 | 12704283 | Hepatitis cholestatic |
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 |
|---|---|---|---|---|---|---|
| 127042833 | 12704283 | 1 | 201607 | 0 | ||
| 127042833 | 12704283 | 2 | 201607 | 20160728 | 0 | |
| 127042833 | 12704283 | 3 | 20160729 | 0 | ||
| 127042833 | 12704283 | 4 | 20160729 | 0 | ||
| 127042833 | 12704283 | 5 | 201607 | 0 | ||
| 127042833 | 12704283 | 6 | 201607 | 20160729 | 0 | |
| 127042833 | 12704283 | 7 | 201607 | 0 | ||
| 127042833 | 12704283 | 8 | 201607 | 20160729 | 0 | |
| 127042833 | 12704283 | 9 | 201607 | 0 | ||
| 127042833 | 12704283 | 10 | 201607 | 20160729 | 0 |