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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121454223 | 12145422 | 3 | F | 20120306 | 20160708 | 20160304 | 20160715 | EXP | US-ROCHE-1047112 | ROCHE | 50.40 | YR | F | Y | 80.60000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121454223 | 12145422 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE:28/FEB/2012 | 962792 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 121454223 | 12145422 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE:28/FEB/2012 | 6102999 | 0 | INFUSION | Q3W | |||||||
| 121454223 | 12145422 | 3 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE:28/FEB/2012 | 63323017260 | 0 | INFUSION | Q3W | |||||||
| 121454223 | 12145422 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | CAPSULE | ||||||||||
| 121454223 | 12145422 | 5 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | TABLET | ||||||||||
| 121454223 | 12145422 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | TABLET | ||||||||||
| 121454223 | 12145422 | 7 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 0 | TABLET | ||||||||||
| 121454223 | 12145422 | 8 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 0 | 7.5 | MG | TABLET | QD | |||||||
| 121454223 | 12145422 | 9 | C | PROCHLORPERAZINE MALEATE. | PROCHLORPERAZINE MALEATE | 1 | Oral | 0 | 10 | MG | TABLET | ||||||||
| 121454223 | 12145422 | 10 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 0 | 40 | MG | TABLET | ||||||||
| 121454223 | 12145422 | 11 | C | NEULASTA | PEGFILGRASTIM | 1 | Unknown | 125031 | 2.6 | MG | |||||||||
| 121454223 | 12145422 | 12 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE:28/FEB/2012 | 101486,101515 | 9900 | 840 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121454223 | 12145422 | 1 | HER-2 positive breast cancer |
| 121454223 | 12145422 | 2 | HER-2 positive breast cancer |
| 121454223 | 12145422 | 3 | HER-2 positive breast cancer |
| 121454223 | 12145422 | 12 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121454223 | 12145422 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121454223 | 12145422 | Constipation | |
| 121454223 | 12145422 | Liver function test increased | |
| 121454223 | 12145422 | Pancytopenia |
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 |
|---|---|---|---|---|---|---|
| 121454223 | 12145422 | 1 | 20120228 | 0 | ||
| 121454223 | 12145422 | 2 | 20120228 | 0 | ||
| 121454223 | 12145422 | 3 | 20120228 | 0 | ||
| 121454223 | 12145422 | 5 | 20111223 | 0 | ||
| 121454223 | 12145422 | 6 | 20120224 | 0 | ||
| 121454223 | 12145422 | 9 | 20120224 | 0 | ||
| 121454223 | 12145422 | 10 | 20120101 | 0 | ||
| 121454223 | 12145422 | 11 | 20120229 | 0 | ||
| 121454223 | 12145422 | 12 | 20120228 | 0 |