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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117774494 | 11777449 | 4 | F | 20150522 | 20160913 | 20151125 | 20160921 | EXP | ES-SA-2015SA190249 | AVENTIS | 85.00 | YR | E | F | Y | 0.00000 | 20160921 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117774494 | 11777449 | 1 | PS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | D | UNKNOWN | 20449 | 115 | MG | Q3W | ||||||
| 117774494 | 11777449 | 2 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | D | 20449 | 115 | MG | Q3W | |||||||
| 117774494 | 11777449 | 3 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | D | 1147052 | 0 | 840 | MG | /cycle | |||||
| 117774494 | 11777449 | 4 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE | D | 1147052 | 0 | 420 | MG | Q3W | |||||
| 117774494 | 11777449 | 5 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 8MG/KG?LOADING DOSE | D | UNKNOWN | 0 | 8 | MG/KG | ||||||
| 117774494 | 11777449 | 6 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6MG/KG?MAINTENANCE DOSE | D | UNKNOWN | 0 | 6 | MG/KG | Q3W | |||||
| 117774494 | 11777449 | 7 | C | STILNOX | ZOLPIDEM TARTRATE | 1 | 0 | 5 | MG | QD | |||||||||
| 117774494 | 11777449 | 8 | C | SERC | BETAHISTINE HYDROCHLORIDE | 1 | 0 | 16 | MG | QD | |||||||||
| 117774494 | 11777449 | 9 | C | BEGLAN | 2 | DOSE: 1 (UNITS NOT REPORTED) | 0 | Q12H | |||||||||||
| 117774494 | 11777449 | 10 | C | PSYLLIUM | PLANTAGO SEED | 1 | 0 | ||||||||||||
| 117774494 | 11777449 | 11 | C | FENTANILO | FENTANYL | 1 | 1/72 H | 0 | |||||||||||
| 117774494 | 11777449 | 12 | C | INALACOR | 2 | DOSE: 1 (UNITS NOT REPORTED) | 0 | Q12H | |||||||||||
| 117774494 | 11777449 | 13 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | 0 | QD | |||||||||||
| 117774494 | 11777449 | 14 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | QD | |||||||||||
| 117774494 | 11777449 | 15 | C | ASPIRIN. | ASPIRIN | 1 | 0 | QD | |||||||||||
| 117774494 | 11777449 | 16 | C | ENALAPRIL | ENALAPRIL | 1 | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117774494 | 11777449 | 1 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 2 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 3 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 4 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 5 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 6 | HER-2 positive breast cancer |
| 117774494 | 11777449 | 7 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117774494 | 11777449 | OT |
| 117774494 | 11777449 | DE |
| 117774494 | 11777449 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117774494 | 11777449 | Asthma | |
| 117774494 | 11777449 | Cardiac failure | |
| 117774494 | 11777449 | Cardiac failure congestive | |
| 117774494 | 11777449 | Respiratory 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 |
|---|---|---|---|---|---|---|
| 117774494 | 11777449 | 1 | 20121127 | 20121127 | 0 | |
| 117774494 | 11777449 | 2 | 20130312 | 20130312 | 0 | |
| 117774494 | 11777449 | 3 | 20121127 | 20121127 | 0 | |
| 117774494 | 11777449 | 4 | 20121218 | 20150608 | 0 | |
| 117774494 | 11777449 | 5 | 20121127 | 20121127 | 0 | |
| 117774494 | 11777449 | 6 | 20121218 | 20150608 | 0 | |
| 117774494 | 11777449 | 7 | 20121116 | 0 | ||
| 117774494 | 11777449 | 8 | 199601 | 0 | ||
| 117774494 | 11777449 | 13 | 20150522 | 20150529 | 0 | |
| 117774494 | 11777449 | 14 | 20150522 | 20150529 | 0 | |
| 117774494 | 11777449 | 15 | 20150522 | 20150529 | 0 | |
| 117774494 | 11777449 | 16 | 20150522 | 20150529 | 0 |