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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123861065 | 12386106 | 5 | F | 20151031 | 20160719 | 20160519 | 20160727 | EXP | US-TAKEDA-2016MPI004063 | TAKEDA | 64.50 | YR | F | Y | 47.00000 | KG | 20160726 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123861065 | 12386106 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | 2 MG, UNK | 21602 | 2 | MG | INJECTION | |||||||
| 123861065 | 12386106 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 2835 MG, UNK | 0 | 2835 | MG | ||||||||
| 123861065 | 12386106 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | UNK | 0 | ||||||||||
| 123861065 | 12386106 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 30 MG, BID | Y | 0 | 30 | MG | BID | ||||||
| 123861065 | 12386106 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 25 MG, BID | Y | 0 | 25 | MG | BID | ||||||
| 123861065 | 12386106 | 6 | C | CALCIUM 500+D | CALCIUMVITAMIN D | 1 | Oral | UNK, BID | U | 0 | BID | ||||||||
| 123861065 | 12386106 | 7 | C | COREG | CARVEDILOL | 1 | Oral | 3.125 MG, BID | U | 0 | 3.125 | MG | BID | ||||||
| 123861065 | 12386106 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 0.5 MG, UNK | U | 0 | .5 | MG | |||||||
| 123861065 | 12386106 | 9 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 15 MG, QD | U | 0 | 15 | MG | QD | ||||||
| 123861065 | 12386106 | 10 | C | MAG-OX | MAGNESIUM OXIDE | 1 | Oral | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 123861065 | 12386106 | 11 | C | PROTONIX /00661201/ | OMEPRAZOLE | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 123861065 | 12386106 | 12 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, UNK | U | 0 | 4 | MG | |||||||
| 123861065 | 12386106 | 13 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | 800 MG, BID | U | 0 | 800 | MG | BID | ||||||
| 123861065 | 12386106 | 14 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Oral | 5000 IU, UNK | U | 0 | 5000 | IU | |||||||
| 123861065 | 12386106 | 15 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 60 MG, Q6HR | U | 0 | 60 | MG | Q6H | ||||||
| 123861065 | 12386106 | 16 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, TID | U | 0 | 300 | MG | TID | ||||||
| 123861065 | 12386106 | 17 | C | LIDOCAINE. | LIDOCAINE | 1 | Topical | U | 0 | PATCH | |||||||||
| 123861065 | 12386106 | 18 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 123861065 | 12386106 | 19 | C | OXYCODONE | OXYCODONE | 1 | Oral | 5 MG, Q3HR | U | 0 | 5 | MG | Q3H | ||||||
| 123861065 | 12386106 | 20 | C | SULFAMETHOXAZOLE-TRIMETHOPRIM (SMZ) | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400 MG-80MG QD | U | 0 | QD | ||||||||
| 123861065 | 12386106 | 21 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123861065 | 12386106 | 1 | Prophylaxis against graft versus host disease |
| 123861065 | 12386106 | 2 | Prophylaxis against graft versus host disease |
| 123861065 | 12386106 | 3 | Graft versus host disease in gastrointestinal tract |
| 123861065 | 12386106 | 4 | Graft versus host disease |
| 123861065 | 12386106 | 8 | Anxiety |
| 123861065 | 12386106 | 12 | Nausea |
| 123861065 | 12386106 | 18 | Pain |
| 123861065 | 12386106 | 19 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123861065 | 12386106 | LT |
| 123861065 | 12386106 | OT |
| 123861065 | 12386106 | HO |
| 123861065 | 12386106 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123861065 | 12386106 | Pneumonia pneumococcal | |
| 123861065 | 12386106 | Progressive multifocal leukoencephalopathy | |
| 123861065 | 12386106 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 123861065 | 12386106 | 1 | 20150721 | 20150724 | 0 | |
| 123861065 | 12386106 | 2 | 20150724 | 20150725 | 0 | |
| 123861065 | 12386106 | 3 | 20151019 | 20160121 | 0 | |
| 123861065 | 12386106 | 4 | 20150923 | 0 | ||
| 123861065 | 12386106 | 5 | 20151123 | 0 |