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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126241681 | 12624168 | 1 | I | 20140526 | 20160802 | 20160805 | 20160805 | EXP | FR-ROCHE-1808091 | ROCHE | 8.00 | YR | F | Y | 20.00000 | KG | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126241681 | 12624168 | 1 | PS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 450 | MG | BID | |||||||
| 126241681 | 12624168 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 450 | MG | BID | |||||||
| 126241681 | 12624168 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 50722 | 450 | MG | BID | |||||||
| 126241681 | 12624168 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 0 | 1.6 | MG | BID | |||||||
| 126241681 | 12624168 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 0 | 1.8 | MG | BID | |||||||
| 126241681 | 12624168 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 0 | 1.6 | MG | BID | |||||||
| 126241681 | 12624168 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 0 | 2 | MG | BID | |||||||
| 126241681 | 12624168 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 1.8 UG/L | U | 0 | BID | ||||||||
| 126241681 | 12624168 | 9 | C | BETA-CAROTENE FORTE | 2 | Unknown | 0 | 40 | MG | QD | |||||||||
| 126241681 | 12624168 | 10 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | BEFORE MEALS. | 0 | 75000 | IU | QID | |||||||
| 126241681 | 12624168 | 11 | C | ERYTHROCINE | ERYTHROMYCIN | 1 | Oral | 0 | 85 | MG | QD | ||||||||
| 126241681 | 12624168 | 12 | C | FORTUM | CEFTAZIDIME | 1 | Intravenous (not otherwise specified) | 0 | .5 | G | BID | ||||||||
| 126241681 | 12624168 | 13 | C | FORTUM | CEFTAZIDIME | 1 | Oral | 0 | 2 | G | BID | ||||||||
| 126241681 | 12624168 | 14 | C | LASILIX | FUROSEMIDE | 1 | Oral | 0 | 5 | MG | BID | ||||||||
| 126241681 | 12624168 | 15 | C | MOPRAL | OMEPRAZOLE SODIUM | 1 | Oral | 0 | 20 | MG | QD | ||||||||
| 126241681 | 12624168 | 16 | C | NOVOMIX | INSULIN ASPART | 1 | Intravenous (not otherwise specified) | FLEX PEN (100 U/ML) | 0 | 8 | IU | BID | |||||||
| 126241681 | 12624168 | 17 | C | URSODESOXYCHOLIC ACID | URSODIOL | 1 | Oral | 0 | 200 | MG | BID | ||||||||
| 126241681 | 12624168 | 18 | C | UVESTEROL | ASCORBIC ACIDERGOCALCIFEROLRETINOLTOCOPHEROL | 1 | Respiratory (inhalation) | 0 | 3 | ML | QD | ||||||||
| 126241681 | 12624168 | 19 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Unknown | 0 | 6 | MG | QD | ||||||||
| 126241681 | 12624168 | 20 | C | VITAMINE A | RETINOL | 1 | 0 | ||||||||||||
| 126241681 | 12624168 | 21 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | 0 | ||||||||||||
| 126241681 | 12624168 | 22 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 | ||||||||||||
| 126241681 | 12624168 | 23 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 126241681 | 12624168 | 24 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 400/80 | 0 | QOD | |||||||||
| 126241681 | 12624168 | 25 | C | CIFLOX (FRANCE) | CIPROFLOXACIN | 1 | Unknown | 0 | 450 | MG | BID | ||||||||
| 126241681 | 12624168 | 26 | C | EUROBIOL | 2 | Unknown | 25000 IU AT 10:00 PM AND 12.500 IU AT 00:00 AM | 0 | 12500 | IU | |||||||||
| 126241681 | 12624168 | 27 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 10 | MG | BID | ||||||||
| 126241681 | 12624168 | 28 | C | VITAMIN K1 | PHYTONADIONE | 1 | Unknown | 0 | 2 | MG | /wk | ||||||||
| 126241681 | 12624168 | 29 | C | UVEDOSE | CHOLECALCIFEROL | 1 | Unknown | 1 AMPULE | 0 | ||||||||||
| 126241681 | 12624168 | 30 | C | PEPTAMEN | 2 | Unknown | EVERY NIGHT. | 0 | 250 | MG | |||||||||
| 126241681 | 12624168 | 31 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Unknown | 5 ML MORNING AND EVENING | 0 | 20 | PCT | ||||||||
| 126241681 | 12624168 | 32 | C | URSOLVAN | URSODIOL | 1 | Unknown | 0 | 200 | MG | BID | ||||||||
| 126241681 | 12624168 | 33 | C | ISOPHANE INSULIN | INSULIN NOS | 1 | Unknown | 100 IU/ML | 0 | ||||||||||
| 126241681 | 12624168 | 34 | C | TOBI NEBULIZER | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126241681 | 12624168 | 1 | Prophylaxis against transplant rejection |
| 126241681 | 12624168 | 4 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126241681 | 12624168 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126241681 | 12624168 | Cytomegalovirus infection | |
| 126241681 | 12624168 | Immunosuppressant drug level increased |
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 |
|---|---|---|---|---|---|---|
| 126241681 | 12624168 | 1 | 20131002 | 0 | ||
| 126241681 | 12624168 | 2 | 20140404 | 0 | ||
| 126241681 | 12624168 | 3 | 20140611 | 0 | ||
| 126241681 | 12624168 | 4 | 20131002 | 0 | ||
| 126241681 | 12624168 | 5 | 20140404 | 0 | ||
| 126241681 | 12624168 | 7 | 20140611 | 0 | ||
| 126241681 | 12624168 | 8 | 20140611 | 0 | ||
| 126241681 | 12624168 | 10 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 11 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 12 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 13 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 14 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 15 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 16 | 20140526 | 20140603 | 0 | |
| 126241681 | 12624168 | 17 | 20140526 | 20140611 | 0 | |
| 126241681 | 12624168 | 18 | 20140527 | 20140611 | 0 | |
| 126241681 | 12624168 | 19 | 20140526 | 20140526 | 0 |