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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127503712 | 12750371 | 2 | F | 20160716 | 20160922 | 20160915 | 20160929 | EXP | FR-ASTELLAS-2016US035394 | ASTELLAS | 18.59 | YR | F | Y | 0.00000 | 20160929 | OT | FR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127503712 | 12750371 | 1 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 2 DF (1 MG), TWICE DAILY (SINCE SEVERAL YEARS) | Y | N | 50708 | 2 | DF | FORMULATION UNKNOWN | BID | ||||
| 127503712 | 12750371 | 2 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2 MG, MORNING AND NIGHT | U | N | 50708 | 2 | MG | FORMULATION UNKNOWN | QD | ||||
| 127503712 | 12750371 | 3 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Oral | 4 DF, IN ONE INTAKE | D | 0 | 4 | DF | FORMULATION UNKNOWN | ||||||
| 127503712 | 12750371 | 4 | SS | KALETRA | LOPINAVIRRITONAVIR | 1 | Oral | U | 0 | 2 | DF | FORMULATION UNKNOWN | BID | ||||||
| 127503712 | 12750371 | 5 | SS | CEFTRIAXONE. | CEFTRIAXONE | 1 | Unknown | 500 MG, IN ONE INTAKE. | D | 0 | 500 | MG | FORMULATION UNKNOWN | ||||||
| 127503712 | 12750371 | 6 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | U | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 127503712 | 12750371 | 7 | C | ORAP | PIMOZIDE | 1 | Unknown | 1 MG, ONCE DAILY (FOR THE PAST FEW YEARS) | D | U | 0 | 1 | MG | FORMULATION UNKNOWN | QD | ||||
| 127503712 | 12750371 | 8 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | D | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | |||||
| 127503712 | 12750371 | 9 | C | DESOGESTREL | DESOGESTREL | 1 | Unknown | D | U | 0 | 1 | DF | TABLET | QD | |||||
| 127503712 | 12750371 | 10 | C | ELLAONE | ULIPRISTAL ACETATE | 1 | Unknown | 1 SINGLE DOSE | D | U | 0 | 1 | DF | FORMULATION UNKNOWN | |||||
| 127503712 | 12750371 | 11 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0.25 MG, AS NEEDED | D | U | 0 | .25 | MG | FORMULATION UNKNOWN | |||||
| 127503712 | 12750371 | 12 | C | VENTOLINE /00139501/ | ALBUTEROL | 1 | Unknown | UNK UNK, AS NEEDED | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127503712 | 12750371 | 1 | Heart transplant |
| 127503712 | 12750371 | 3 | Prophylaxis urinary tract infection |
| 127503712 | 12750371 | 4 | Prophylaxis against HIV infection |
| 127503712 | 12750371 | 5 | Product used for unknown indication |
| 127503712 | 12750371 | 6 | Prophylaxis against HIV infection |
| 127503712 | 12750371 | 7 | Product used for unknown indication |
| 127503712 | 12750371 | 8 | Product used for unknown indication |
| 127503712 | 12750371 | 9 | Product used for unknown indication |
| 127503712 | 12750371 | 10 | Product used for unknown indication |
| 127503712 | 12750371 | 11 | Anxiety |
| 127503712 | 12750371 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127503712 | 12750371 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127503712 | 12750371 | Anxiety | |
| 127503712 | 12750371 | Dyspnoea exertional | |
| 127503712 | 12750371 | Electrocardiogram QT prolonged | |
| 127503712 | 12750371 | Nausea | |
| 127503712 | 12750371 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 127503712 | 12750371 | 1 | 20160718 | 0 | ||
| 127503712 | 12750371 | 2 | 20160723 | 0 | ||
| 127503712 | 12750371 | 3 | 20160716 | 20160716 | 0 | |
| 127503712 | 12750371 | 4 | 20160716 | 20160720 | 0 | |
| 127503712 | 12750371 | 5 | 20160716 | 20160716 | 0 | |
| 127503712 | 12750371 | 6 | 20160716 | 20160720 | 0 | |
| 127503712 | 12750371 | 10 | 20160716 | 0 |