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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126242571 | 12624257 | 1 | I | 20151201 | 20160728 | 20160805 | 20160805 | EXP | US-ROCHE-1804559 | ROCHE | 54.00 | YR | F | Y | 0.00000 | 20160805 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126242571 | 12624257 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | DOSE: 6MG/KG | 103792 | 480 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 126242571 | 12624257 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | DOSE: 6MG/KG | 103792 | 480 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 126242571 | 12624257 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 125409 | 420 | MG | SOLUTION FOR INFUSION | ||||||||
| 126242571 | 12624257 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 125409 | 420 | MG | SOLUTION FOR INFUSION | ||||||||
| 126242571 | 12624257 | 5 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | FREQUENCY: 2 WEEKS ON AND 1 WEEKS OFF. | 0 | 2300 | MG | ||||||||
| 126242571 | 12624257 | 6 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | FREQUENCY: 2 WEEKS ON AND 1 WEEKS OFF. | 0 | 2300 | MG | ||||||||
| 126242571 | 12624257 | 7 | C | ROCEPHIN | CEFTRIAXONE SODIUM | 1 | Unknown | 63239 | |||||||||||
| 126242571 | 12624257 | 8 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | 0 | ||||||||||||
| 126242571 | 12624257 | 9 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | 0 | ||||||||||||
| 126242571 | 12624257 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | TAPER | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126242571 | 12624257 | 1 | HER-2 positive breast cancer |
| 126242571 | 12624257 | 3 | HER-2 positive breast cancer |
| 126242571 | 12624257 | 5 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126242571 | 12624257 | HO |
| 126242571 | 12624257 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126242571 | 12624257 | Deep vein thrombosis | |
| 126242571 | 12624257 | Dyspnoea | |
| 126242571 | 12624257 | Pleural effusion | |
| 126242571 | 12624257 | Pneumonia | |
| 126242571 | 12624257 | Pulmonary oedema |
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 |
|---|---|---|---|---|---|---|
| 126242571 | 12624257 | 1 | 20150918 | 0 | ||
| 126242571 | 12624257 | 2 | 20151228 | 0 | ||
| 126242571 | 12624257 | 3 | 20150918 | 0 | ||
| 126242571 | 12624257 | 4 | 20151228 | 0 | ||
| 126242571 | 12624257 | 5 | 20150918 | 0 | ||
| 126242571 | 12624257 | 6 | 20151228 | 0 | ||
| 126242571 | 12624257 | 10 | 20151208 | 20151223 | 0 |