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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127435721 | 12743572 | 1 | I | 20150207 | 20150423 | 20160914 | 20160914 | EXP | KR-SA-2015SA053414 | AVENTIS | 36.00 | YR | A | F | Y | 52.00000 | KG | 20160914 | MD | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127435721 | 12743572 | 1 | PS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | UNKNOWN | 20449 | 112.5 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 2 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 840 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 3 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 420 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 4 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 420 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 5 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 420 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 6 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 0 | 420 | MG | INJECTION | Q3W | |||||||
| 127435721 | 12743572 | 7 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 0 | 420 | MG | INJECTION | Q3W | |||||||
| 127435721 | 12743572 | 8 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 300 | MG | INJECTION | Q3W | ||||||
| 127435721 | 12743572 | 9 | C | MAXIPIME | CEFEPIME HYDROCHLORIDE | 1 | Unknown | 0 | 6000 | MG | INJECTION | TID | |||||||
| 127435721 | 12743572 | 10 | C | CURAN | RANITIDINE HYDROCHLORIDE | 1 | Oral | 0 | 300 | MG | BID | ||||||||
| 127435721 | 12743572 | 11 | C | UNASYN | AMPICILLIN SODIUMSULBACTAM SODIUM | 1 | Oral | 0 | 1125 | MG | TID | ||||||||
| 127435721 | 12743572 | 12 | C | LEGALON | MILK THISTLE | 1 | Oral | 0 | 420 | MG | TID | ||||||||
| 127435721 | 12743572 | 13 | C | URSA | 2 | Oral | 100 MG, 3 IN 1 DAY | 0 | 100 | MG | TID | ||||||||
| 127435721 | 12743572 | 14 | C | ADELAVIN | 2 | Unknown | 0 | 2 | ML | INJECTION | QD | ||||||||
| 127435721 | 12743572 | 15 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 0 | 2 | MG | QD | ||||||||
| 127435721 | 12743572 | 16 | C | STILNOX | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 6.25 | MG | QD | ||||||||
| 127435721 | 12743572 | 17 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 0 | 300 | MG | TID | ||||||||
| 127435721 | 12743572 | 18 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1300 | MG | QD | ||||||||
| 127435721 | 12743572 | 19 | C | PENIRAMIN | 2 | Intravenous (not otherwise specified) | 0 | 4 | MG | ||||||||||
| 127435721 | 12743572 | 20 | C | PETHIDINE | MEPERIDINE | 1 | Intramuscular | 0 | 25 | MG | INJECTION | ||||||||
| 127435721 | 12743572 | 21 | C | TANTUM | BENZYDAMINE HYDROCHLORIDE | 1 | Oral | DOSE:20 %GARGLE 200ML/BTL | 0 | ||||||||||
| 127435721 | 12743572 | 22 | C | DENOGAN | PROPACETAMOL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | |||||||||
| 127435721 | 12743572 | 23 | C | SMECTA | MONTMORILLONITE | 1 | Oral | 60 ML, 08-FEB-2015 | 0 | ||||||||||
| 127435721 | 12743572 | 24 | C | ULCERMIN | SUCRALFATE | 1 | Oral | 0 | 45 | ML | ORAL SUSPENSION | ||||||||
| 127435721 | 12743572 | 25 | C | STILLEN | 2 | Oral | 0 | 180 | MG | ||||||||||
| 127435721 | 12743572 | 26 | C | KYTRIL | GRANISETRON HYDROCHLORIDE | 1 | Oral | 0 | 2 | MG | |||||||||
| 127435721 | 12743572 | 27 | C | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | 0 | 729 | MG | /cycle | ||||||||
| 127435721 | 12743572 | 28 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | 16 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127435721 | 12743572 | 1 | Breast cancer metastatic |
| 127435721 | 12743572 | 2 | Breast cancer metastatic |
| 127435721 | 12743572 | 3 | Breast cancer metastatic |
| 127435721 | 12743572 | 4 | Breast cancer metastatic |
| 127435721 | 12743572 | 5 | Breast cancer metastatic |
| 127435721 | 12743572 | 6 | Breast cancer metastatic |
| 127435721 | 12743572 | 7 | Breast cancer metastatic |
| 127435721 | 12743572 | 8 | Breast cancer metastatic |
| 127435721 | 12743572 | 9 | Catheter site infection |
| 127435721 | 12743572 | 10 | Catheter site infection |
| 127435721 | 12743572 | 11 | Catheter site infection |
| 127435721 | 12743572 | 12 | Aspartate aminotransferase increased |
| 127435721 | 12743572 | 13 | Aspartate aminotransferase increased |
| 127435721 | 12743572 | 14 | Aspartate aminotransferase increased |
| 127435721 | 12743572 | 15 | Diarrhoea |
| 127435721 | 12743572 | 16 | Insomnia |
| 127435721 | 12743572 | 17 | Catheter site infection |
| 127435721 | 12743572 | 18 | Pyrexia |
| 127435721 | 12743572 | 19 | Infection prophylaxis |
| 127435721 | 12743572 | 20 | Febrile neutropenia |
| 127435721 | 12743572 | 21 | Infection prophylaxis |
| 127435721 | 12743572 | 22 | Febrile neutropenia |
| 127435721 | 12743572 | 23 | Diarrhoea |
| 127435721 | 12743572 | 26 | Prophylaxis of nausea and vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127435721 | 12743572 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127435721 | 12743572 | Alanine aminotransferase increased | |
| 127435721 | 12743572 | Anaemia | |
| 127435721 | 12743572 | Aspartate aminotransferase increased | |
| 127435721 | 12743572 | Blood albumin decreased | |
| 127435721 | 12743572 | Blood calcium decreased | |
| 127435721 | 12743572 | Blood phosphorus decreased | |
| 127435721 | 12743572 | Diarrhoea | |
| 127435721 | 12743572 | Febrile neutropenia | |
| 127435721 | 12743572 | Hypokalaemia | |
| 127435721 | 12743572 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 127435721 | 12743572 | 1 | 20150129 | 0 | ||
| 127435721 | 12743572 | 2 | 20150129 | 0 | ||
| 127435721 | 12743572 | 3 | 20150223 | 0 | ||
| 127435721 | 12743572 | 4 | 20150316 | 0 | ||
| 127435721 | 12743572 | 5 | 20150406 | 0 | ||
| 127435721 | 12743572 | 6 | 20150427 | 0 | ||
| 127435721 | 12743572 | 7 | 20150518 | 0 | ||
| 127435721 | 12743572 | 8 | 20150129 | 0 | ||
| 127435721 | 12743572 | 9 | 20150207 | 20150327 | 0 | |
| 127435721 | 12743572 | 10 | 20150128 | 20150406 | 0 | |
| 127435721 | 12743572 | 11 | 20150216 | 20150304 | 0 | |
| 127435721 | 12743572 | 12 | 20150304 | 0 | ||
| 127435721 | 12743572 | 13 | 20150304 | 20150330 | 0 | |
| 127435721 | 12743572 | 14 | 20150304 | 20150330 | 0 | |
| 127435721 | 12743572 | 15 | 20150305 | 20150329 | 0 | |
| 127435721 | 12743572 | 16 | 20150323 | 20150330 | 0 | |
| 127435721 | 12743572 | 17 | 20150223 | 20150308 | 0 | |
| 127435721 | 12743572 | 18 | 20150208 | 20150330 | 0 | |
| 127435721 | 12743572 | 19 | 20150128 | 0 | ||
| 127435721 | 12743572 | 20 | 20150128 | 20150327 | 0 | |
| 127435721 | 12743572 | 21 | 20150128 | 20150406 | 0 | |
| 127435721 | 12743572 | 22 | 20150207 | 20150327 | 0 | |
| 127435721 | 12743572 | 23 | 20150305 | 0 | ||
| 127435721 | 12743572 | 24 | 20150216 | 20150223 | 0 | |
| 127435721 | 12743572 | 25 | 20150216 | 20150223 | 0 | |
| 127435721 | 12743572 | 26 | 20150223 | 20150223 | 0 | |
| 127435721 | 12743572 | 27 | 20150223 | 20150223 | 0 | |
| 127435721 | 12743572 | 28 | 20150128 | 0 |