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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126054742 | 12605474 | 2 | F | 20121221 | 20160729 | 20160729 | 20160802 | EXP | VN-ROCHE-1802326 | ROCHE | 10.00 | YR | Y | 0.00000 | 20160802 | MD | VN | VN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126054742 | 12605474 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 50722 | |||||||||
| 126054742 | 12605474 | 2 | SS | SIMULECT | BASILIXIMAB | 1 | Unknown | DAY 0 AND DAY 4 | U | 0 | 10 | MG | |||||||
| 126054742 | 12605474 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | ||||||||||
| 126054742 | 12605474 | 4 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | U | 0 | ||||||||||
| 126054742 | 12605474 | 5 | SS | PREDNISON | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 126054742 | 12605474 | 6 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | 0 | ||||||||||||
| 126054742 | 12605474 | 7 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 0 | |||||||||||
| 126054742 | 12605474 | 8 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | TABLET | ||||||||||
| 126054742 | 12605474 | 9 | C | NAHCO3 | SODIUM BICARBONATE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126054742 | 12605474 | 1 | Immunosuppressant drug therapy |
| 126054742 | 12605474 | 2 | Immunosuppressant drug therapy |
| 126054742 | 12605474 | 3 | Prophylaxis |
| 126054742 | 12605474 | 4 | Immunosuppressant drug therapy |
| 126054742 | 12605474 | 5 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126054742 | 12605474 | OT |
| 126054742 | 12605474 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126054742 | 12605474 | Alanine aminotransferase increased | |
| 126054742 | 12605474 | Aspartate aminotransferase increased | |
| 126054742 | 12605474 | Cytomegalovirus infection | |
| 126054742 | 12605474 | Diarrhoea | |
| 126054742 | 12605474 | Haemoglobin decreased | |
| 126054742 | 12605474 | Neutropenia | |
| 126054742 | 12605474 | Pneumonia | |
| 126054742 | 12605474 | Thrombocytopenia | |
| 126054742 | 12605474 | Transplant rejection | |
| 126054742 | 12605474 | Vomiting | |
| 126054742 | 12605474 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 126054742 | 12605474 | 1 | 201212 | 0 |