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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122211502 | 12221150 | 2 | F | 20150516 | 20160927 | 20160330 | 20160929 | EXP | DE-ROCHE-1582141 | ROCHE | 44.00 | YR | F | Y | 77.00000 | KG | 20160929 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122211502 | 12221150 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | H0080 | 125409 | 840 | MG | SOLUTION FOR INFUSION | ||||||
| 122211502 | 12221150 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINANCE DOSE, DATE OF LAST DOSE PRIOR TO SAE 11/JUN/2015 | H0080 | 125409 | 420 | MG | SOLUTION FOR INFUSION | ||||||
| 122211502 | 12221150 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 09/JUL/2015 | H0080 | 125409 | SOLUTION FOR INFUSION | ||||||||
| 122211502 | 12221150 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 09/JUL/2015 | H0080 | 125409 | |||||||||
| 122211502 | 12221150 | 5 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | N1030H03 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 122211502 | 12221150 | 6 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINACE DOSE, DATE OF LAST DOSE PRIOR TO SAE:11/JUN/2015 | N1030H03 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | ||||||
| 122211502 | 12221150 | 7 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N1030H03 | 103792 | SOLUTION FOR INFUSION | |||||||||
| 122211502 | 12221150 | 8 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 09/JUL/2015 | N1030H03 | 103792 | SOLUTION FOR INFUSION | ||||||||
| 122211502 | 12221150 | 9 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE:18/JUN/2015 | 4GY0131 | 0 | 158 | MG | INFUSION | ||||||
| 122211502 | 12221150 | 10 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 23/JUL/2015 | 4GY0131 | 0 | 119 | MG | INFUSION | ||||||
| 122211502 | 12221150 | 11 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE: 18/JUN/2015 | 14F22DE | 0 | 40 | MG | INFUSION | ||||||
| 122211502 | 12221150 | 12 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE OF PRIOR TO SAE: 23/JUL/2015 | 14F22DE | 0 | 30 | MG | INFUSION | ||||||
| 122211502 | 12221150 | 13 | C | APREPITANT. | APREPITANT | 1 | Unknown | 0 | |||||||||||
| 122211502 | 12221150 | 14 | C | PREDNISOLON | PREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 122211502 | 12221150 | 15 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | |||||||||||
| 122211502 | 12221150 | 16 | C | Granisetron | GRANISETRON | 1 | Unknown | 0 | |||||||||||
| 122211502 | 12221150 | 17 | C | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 122211502 | 12221150 | 18 | C | GRANISETRON | GRANISETRON | 1 | Unknown | 0 | 1 | G |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122211502 | 12221150 | 1 | HER-2 positive breast cancer |
| 122211502 | 12221150 | 5 | HER-2 positive breast cancer |
| 122211502 | 12221150 | 9 | HER-2 positive breast cancer |
| 122211502 | 12221150 | 11 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122211502 | 12221150 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122211502 | 12221150 | Pneumonia | |
| 122211502 | 12221150 | Pyrexia | |
| 122211502 | 12221150 | Urinary 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 |
|---|---|---|---|---|---|---|
| 122211502 | 12221150 | 1 | 20150512 | 0 | ||
| 122211502 | 12221150 | 2 | 20150602 | 0 | ||
| 122211502 | 12221150 | 3 | 20150611 | 0 | ||
| 122211502 | 12221150 | 4 | 20150709 | 0 | ||
| 122211502 | 12221150 | 5 | 20150512 | 0 | ||
| 122211502 | 12221150 | 6 | 20150602 | 0 | ||
| 122211502 | 12221150 | 7 | 20150611 | 0 | ||
| 122211502 | 12221150 | 8 | 20150709 | 0 | ||
| 122211502 | 12221150 | 9 | 20150512 | 20150524 | 0 | |
| 122211502 | 12221150 | 10 | 20150702 | 20150730 | 0 | |
| 122211502 | 12221150 | 11 | 20150512 | 20150624 | 0 | |
| 122211502 | 12221150 | 12 | 20150702 | 20150730 | 0 | |
| 122211502 | 12221150 | 13 | 20150512 | 0 | ||
| 122211502 | 12221150 | 14 | 2002 | 0 | ||
| 122211502 | 12221150 | 15 | 20150512 | 0 | ||
| 122211502 | 12221150 | 16 | 20150512 | 0 | ||
| 122211502 | 12221150 | 17 | 20150512 | 0 | ||
| 122211502 | 12221150 | 18 | 20150512 | 0 |