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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123053903 | 12305390 | 3 | F | 20151013 | 20160801 | 20160426 | 20160810 | EXP | JP-TEVA-652682ISR | TEVA | 69.66 | YR | M | Y | 53.00000 | KG | 20160810 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123053903 | 12305390 | 1 | PS | E-FEN BUCCAL | FENTANYL CITRATE | 1 | Buccal | DAILY DOSE: 100-200MICROG | Y | 21947 | 50 | UG | TABLET | ||||||
| 123053903 | 12305390 | 2 | SS | Fentos | FENTANYL | 1 | Transdermal | 6 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 3 | SS | Fentos | FENTANYL | 1 | Transdermal | 8 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 4 | SS | Fentos | FENTANYL | 1 | Transdermal | 10 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 5 | SS | Fentos | FENTANYL | 1 | 6 MILLIGRAM DAILY; | Y | 0 | ||||||||||
| 123053903 | 12305390 | 6 | SS | OXINORM | OXYCODONE HYDROCHLORIDE | 1 | Oral | Y | 0 | 5 | MG | ||||||||
| 123053903 | 12305390 | 7 | SS | GEMZAR | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous drip | 1.5 GRAM DAILY; | 0 | 1.5 | MG | ||||||||
| 123053903 | 12305390 | 8 | SS | GEMZAR | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous drip | 1.5 GRAM DAILY; | 0 | 1.5 | MG | ||||||||
| 123053903 | 12305390 | 9 | SS | GEMZAR | GEMCITABINE HYDROCHLORIDE | 1 | Intravenous drip | 1.5 GRAM DAILY; | 0 | 1.5 | MG | ||||||||
| 123053903 | 12305390 | 10 | SS | TRYPTANOL | AMITRIPTYLINE | 1 | Oral | 30 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 11 | SS | LYRICA | PREGABALIN | 1 | Oral | 300 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 12 | C | LOXOPROFEN SODIUM HYDRATE | LOXOPROFEN SODIUM DIHYDRATE | 1 | Oral | 180 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 13 | C | FAMOTIDINE D | FAMOTIDINE | 1 | Oral | 40 MILLIGRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 14 | C | SHAKUYAKU KANZO TO | 2 | Oral | 5 GRAM DAILY; ONGOING | 0 | |||||||||||
| 123053903 | 12305390 | 15 | C | NINJINTO | 2 | Oral | 5 GRAM DAILY; ONGOING | 0 | |||||||||||
| 123053903 | 12305390 | 16 | C | PROCESSED ACONITE ROOT | ACONITUM NAPELLUS ROOT | 1 | Oral | 2 GRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 17 | C | PANTETHINE | PANTETHINE | 1 | Oral | 1.5 GRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 18 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | 1.5 GRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 19 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 300 MILLIGRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 20 | C | SENNOSIDE | SENNOSIDES | 1 | Oral | 24 MILLIGRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 21 | C | MS ONSHIPPU | 2 | Transdermal | 2 DOSAGE FORMS DAILY; ONGOING | 0 | |||||||||||
| 123053903 | 12305390 | 22 | C | IDOMETHINE | INDOMETHACIN | 1 | Transdermal | 35 GRAM DAILY; | 0 | ||||||||||
| 123053903 | 12305390 | 23 | C | NOVAMIN | PROCHLORPERAZINE MALEATE | 1 | Oral | 15 MILLIGRAM DAILY; ONGOING | 0 | ||||||||||
| 123053903 | 12305390 | 24 | C | DECADRON | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 6.6 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 25 | C | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | .75 MILLIGRAM DAILY; | Y | 0 | |||||||||
| 123053903 | 12305390 | 26 | C | BIO-THREE | HERBALS | 1 | Oral | 3 DOSAGE FORMS DAILY; | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123053903 | 12305390 | 1 | Breakthrough pain |
| 123053903 | 12305390 | 2 | Cancer pain |
| 123053903 | 12305390 | 6 | Breakthrough pain |
| 123053903 | 12305390 | 7 | Chemotherapy |
| 123053903 | 12305390 | 10 | Cancer pain |
| 123053903 | 12305390 | 11 | Cancer pain |
| 123053903 | 12305390 | 12 | Cancer pain |
| 123053903 | 12305390 | 13 | Prophylaxis |
| 123053903 | 12305390 | 21 | Pain |
| 123053903 | 12305390 | 22 | Cancer pain |
| 123053903 | 12305390 | 23 | Nausea |
| 123053903 | 12305390 | 24 | Nausea |
| 123053903 | 12305390 | 25 | Prophylaxis of nausea and vomiting |
| 123053903 | 12305390 | 26 | Dysbacteriosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123053903 | 12305390 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123053903 | 12305390 | Delirium | |
| 123053903 | 12305390 | Nausea | |
| 123053903 | 12305390 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 123053903 | 12305390 | 1 | 20150926 | 20151026 | 0 | |
| 123053903 | 12305390 | 2 | 20150919 | 20151001 | 0 | |
| 123053903 | 12305390 | 3 | 20151002 | 20151018 | 0 | |
| 123053903 | 12305390 | 4 | 20151019 | 20151023 | 0 | |
| 123053903 | 12305390 | 5 | 20151024 | 20151028 | 0 | |
| 123053903 | 12305390 | 6 | 20150803 | 20151030 | 0 | |
| 123053903 | 12305390 | 7 | 20151007 | 20151007 | 0 | |
| 123053903 | 12305390 | 8 | 20151014 | 20151014 | 0 | |
| 123053903 | 12305390 | 9 | 20151021 | 20151021 | 0 | |
| 123053903 | 12305390 | 10 | 20150803 | 20151002 | 0 | |
| 123053903 | 12305390 | 11 | 20150803 | 20151002 | 0 | |
| 123053903 | 12305390 | 12 | 20150615 | 20151028 | 0 | |
| 123053903 | 12305390 | 22 | 20151002 | 20151002 | 0 | |
| 123053903 | 12305390 | 23 | 20151002 | 0 | ||
| 123053903 | 12305390 | 24 | 20151007 | 20151021 | 0 | |
| 123053903 | 12305390 | 25 | 20151007 | 20151021 | 0 | |
| 123053903 | 12305390 | 26 | 20151014 | 20151020 | 0 |