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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102069713 | 10206971 | 3 | F | 20121111 | 20160908 | 20140530 | 20160915 | EXP | JP-SA-2014SA068403 | AVENTIS | 4.00 | YR | C | M | Y | 15.20000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102069713 | 10206971 | 1 | PS | THYMOGLOBULINE | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | C1310NC | 103869 | 23 | MG | POWDER FOR SOLUTION FOR INFUSION | QD | ||||||
| 102069713 | 10206971 | 2 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 102069713 | 10206971 | 3 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 102069713 | 10206971 | 4 | SS | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 102069713 | 10206971 | 5 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 102069713 | 10206971 | 6 | C | UROMITEXAN | MESNA | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 8 | C | VENILON | HUMAN IMMUNOGLOBULIN G | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 9 | C | VICCLOX | ACYCLOVIR SODIUM | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 11 | C | GRAN | FILGRASTIM | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 12 | C | URSO | URSODIOL | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 13 | C | OZEX | TOSUFLOXACIN TOSYLATE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 14 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 15 | C | SOLDACTONE | CANRENOATE POTASSIUM | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 16 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 17 | C | GASTER | FAMOTIDINE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 18 | C | FRAGMIN | DALTEPARIN SODIUM | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 19 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 20 | C | SELBEX | TEPRENONE | 1 | 0 | ||||||||||||
| 102069713 | 10206971 | 21 | C | FUNGUARD | MICAFUNGIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102069713 | 10206971 | 1 | Bone marrow conditioning regimen |
| 102069713 | 10206971 | 2 | Bone marrow conditioning regimen |
| 102069713 | 10206971 | 3 | Bone marrow conditioning regimen |
| 102069713 | 10206971 | 4 | Prophylaxis |
| 102069713 | 10206971 | 5 | Prophylaxis against graft versus host disease |
| 102069713 | 10206971 | 6 | Prophylaxis |
| 102069713 | 10206971 | 7 | Prophylaxis |
| 102069713 | 10206971 | 8 | Infection prophylaxis |
| 102069713 | 10206971 | 9 | Infection prophylaxis |
| 102069713 | 10206971 | 10 | Prophylaxis against graft versus host disease |
| 102069713 | 10206971 | 12 | Prophylaxis |
| 102069713 | 10206971 | 13 | Infection prophylaxis |
| 102069713 | 10206971 | 14 | Prophylaxis |
| 102069713 | 10206971 | 15 | Prophylaxis |
| 102069713 | 10206971 | 16 | Nausea |
| 102069713 | 10206971 | 17 | Prophylaxis |
| 102069713 | 10206971 | 18 | Prophylaxis |
| 102069713 | 10206971 | 19 | Prophylaxis |
| 102069713 | 10206971 | 20 | Prophylaxis |
| 102069713 | 10206971 | 21 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102069713 | 10206971 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102069713 | 10206971 | Ascites | |
| 102069713 | 10206971 | Bacterial infection | |
| 102069713 | 10206971 | Cystitis viral | |
| 102069713 | 10206971 | Cytomegalovirus chorioretinitis | |
| 102069713 | 10206971 | Engraftment syndrome | |
| 102069713 | 10206971 | Hypertension | |
| 102069713 | 10206971 | Liver disorder | |
| 102069713 | 10206971 | Mucous membrane disorder | |
| 102069713 | 10206971 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 102069713 | 10206971 | 1 | 20121110 | 20121113 | 0 | |
| 102069713 | 10206971 | 2 | 20121110 | 20121113 | 0 | |
| 102069713 | 10206971 | 3 | 20121110 | 20121113 | 0 | |
| 102069713 | 10206971 | 4 | 20121110 | 20130326 | 0 | |
| 102069713 | 10206971 | 5 | 20121114 | 0 | ||
| 102069713 | 10206971 | 6 | 20121110 | 20121113 | 0 | |
| 102069713 | 10206971 | 7 | 20121114 | 20121114 | 0 | |
| 102069713 | 10206971 | 8 | 20121114 | 0 | ||
| 102069713 | 10206971 | 9 | 20121115 | 20121205 | 0 | |
| 102069713 | 10206971 | 10 | 20121116 | 20121126 | 0 | |
| 102069713 | 10206971 | 11 | 20121120 | 20121203 | 0 | |
| 102069713 | 10206971 | 12 | 20121107 | 20130124 | 0 | |
| 102069713 | 10206971 | 13 | 20121107 | 20121205 | 0 | |
| 102069713 | 10206971 | 14 | 20121110 | 20130128 | 0 | |
| 102069713 | 10206971 | 15 | 20121110 | 20130128 | 0 | |
| 102069713 | 10206971 | 16 | 20121110 | 20121110 | 0 | |
| 102069713 | 10206971 | 17 | 20121110 | 20121212 | 0 | |
| 102069713 | 10206971 | 18 | 20121110 | 20121226 | 0 | |
| 102069713 | 10206971 | 19 | 20121110 | 20121118 | 0 | |
| 102069713 | 10206971 | 20 | 20121213 | 0 | ||
| 102069713 | 10206971 | 21 | 20121110 | 20121220 | 0 |