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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125309262 | 12530926 | 2 | F | 20151227 | 20160819 | 20160706 | 20160824 | EXP | JP-SA-2016SA123525 | AVENTIS | 55.00 | YR | A | M | Y | 64.50000 | KG | 20160824 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125309262 | 12530926 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | UNK | 103869 | 1.5 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | QD | ||||||
| 125309262 | 12530926 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 4 - 6 MG/DAY | UNK | 0 | QD | ||||||||
| 125309262 | 12530926 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 250 - 1500?MG/DAY | UNK | 0 | QD | ||||||||
| 125309262 | 12530926 | 4 | SS | DENOSINE | GANCICLOVIR | 1 | Unknown | 120 - 300?MG/DAY | UNK | 0 | INJECTION | QD | |||||||
| 125309262 | 12530926 | 5 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | 0 | 5 | MG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 6 | C | ACELIO | ACETAMINOPHEN | 1 | 0 | 1000 | MG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 7 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | 40 - 60 MG/DAY | 0 | INJECTION | QD | |||||||||
| 125309262 | 12530926 | 8 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 125309262 | 12530926 | 9 | C | HEPARIN | HEPARIN SODIUM | 1 | DOSE:1000 UNIT(S) | 0 | INJECTION | QD | |||||||||
| 125309262 | 12530926 | 10 | C | TANDETRON | ALPROSTADIL ALFADEX | 1 | 0 | 2000 | UG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 11 | C | TOBRACIN | TOBRAMYCIN | 1 | 0 | 180 | MG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 12 | C | TEICOPLANIN | TEICOPLANIN | 1 | 100 - 800 MG/DAY | 0 | INJECTION | QD | |||||||||
| 125309262 | 12530926 | 13 | C | VENOGLOBULIN IH | HUMAN IMMUNOGLOBULIN G | 1 | 0 | 5 | MG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 14 | C | FIBROGAMMIN P | FACTOR XIII CONCENTRATE (HUMAN) | 1 | DOSE: 6 V/DAY | 0 | INJECTION | QD | |||||||||
| 125309262 | 12530926 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | 40 | MG | INJECTION | QD | ||||||||
| 125309262 | 12530926 | 16 | C | RISPERDAL | RISPERIDONE | 1 | Oral | WHEN HAVING INSOMNIA | 0 | .5 | ML | ORAL SOLUTION | |||||||
| 125309262 | 12530926 | 17 | C | TEPRENONE | TEPRENONE | 1 | Oral | 0 | 50 | MG | TID | ||||||||
| 125309262 | 12530926 | 18 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Oral | 0 | 2.5 | MG | TABLET | BID | |||||||
| 125309262 | 12530926 | 19 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 125309262 | 12530926 | 20 | C | POVIDONE-IODINE. | POVIDONE-IODINE | 1 | GARGLE 6% DILUTED GARGLE SOLUTION 500 ML?1 BOTTLE | 0 | GARGLE | ||||||||||
| 125309262 | 12530926 | 21 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | 50MG | 0 | 25 | MG | TABLET | ||||||||
| 125309262 | 12530926 | 22 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | 25MG | 0 | TABLET | ||||||||||
| 125309262 | 12530926 | 23 | C | ATORVASTATIN | ATORVASTATIN | 1 | 20MG | 0 | 20 | MG | TABLET | ||||||||
| 125309262 | 12530926 | 24 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | 50MG | 0 | 50 | MG | TABLET | ||||||||
| 125309262 | 12530926 | 25 | C | ROZEREM | RAMELTEON | 1 | 8MG | 0 | 8 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125309262 | 12530926 | 1 | Lung transplant rejection |
| 125309262 | 12530926 | 2 | Immunosuppressant drug therapy |
| 125309262 | 12530926 | 3 | Immunosuppressant drug therapy |
| 125309262 | 12530926 | 4 | Cytomegalovirus viraemia |
| 125309262 | 12530926 | 5 | Premedication |
| 125309262 | 12530926 | 6 | Premedication |
| 125309262 | 12530926 | 7 | Immunosuppressant drug therapy |
| 125309262 | 12530926 | 8 | Immunosuppressant drug therapy |
| 125309262 | 12530926 | 9 | Prophylaxis |
| 125309262 | 12530926 | 10 | Prophylaxis |
| 125309262 | 12530926 | 14 | Prophylaxis |
| 125309262 | 12530926 | 15 | Prophylaxis |
| 125309262 | 12530926 | 16 | Insomnia |
| 125309262 | 12530926 | 17 | Prophylaxis |
| 125309262 | 12530926 | 18 | Prophylaxis |
| 125309262 | 12530926 | 19 | Prophylaxis |
| 125309262 | 12530926 | 21 | Prophylaxis |
| 125309262 | 12530926 | 22 | Prophylaxis |
| 125309262 | 12530926 | 23 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125309262 | 12530926 | HO |
| 125309262 | 12530926 | OT |
| 125309262 | 12530926 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125309262 | 12530926 | Cytomegalovirus viraemia | |
| 125309262 | 12530926 | Hypoxia | |
| 125309262 | 12530926 | Nausea | |
| 125309262 | 12530926 | Pyrexia | |
| 125309262 | 12530926 | 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 |
|---|---|---|---|---|---|---|
| 125309262 | 12530926 | 1 | 20151227 | 20160102 | 0 | |
| 125309262 | 12530926 | 2 | 20151222 | 0 | ||
| 125309262 | 12530926 | 3 | 20151213 | 0 | ||
| 125309262 | 12530926 | 4 | 20151218 | 20160424 | 0 | |
| 125309262 | 12530926 | 5 | 20151227 | 20160102 | 0 | |
| 125309262 | 12530926 | 6 | 20151227 | 20151228 | 0 | |
| 125309262 | 12530926 | 7 | 20151213 | 20151231 | 0 | |
| 125309262 | 12530926 | 8 | 20160217 | 0 | ||
| 125309262 | 12530926 | 9 | 20151225 | 20160103 | 0 | |
| 125309262 | 12530926 | 10 | 20151213 | 20160121 | 0 | |
| 125309262 | 12530926 | 11 | 20151222 | 20160111 | 0 | |
| 125309262 | 12530926 | 12 | 20151218 | 20151231 | 0 | |
| 125309262 | 12530926 | 13 | 20151223 | 20160103 | 0 | |
| 125309262 | 12530926 | 14 | 20151225 | 20151227 | 0 | |
| 125309262 | 12530926 | 15 | 20151229 | 20151231 | 0 | |
| 125309262 | 12530926 | 16 | 20151230 | 20160113 | 0 | |
| 125309262 | 12530926 | 17 | 20151228 | 0 | ||
| 125309262 | 12530926 | 18 | 20151228 | 0 | ||
| 125309262 | 12530926 | 19 | 20151213 | 0 | ||
| 125309262 | 12530926 | 20 | 20151213 | 0 |