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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103871087 | 10387108 | 7 | F | 20140805 | 20160628 | 20140815 | 20160707 | EXP | PK-ROCHE-1447681 | ROCHE | 38.00 | YR | F | Y | 0.00000 | 20160707 | MD | PK | PK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103871087 | 10387108 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | 110723,1117807,1148504 | 125409 | 840 | MG | /cycle | ||||||
| 103871087 | 10387108 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 31/MAR/2015?LAST DOSE PRIOR TO SECOND EPISODE OF SEVERE CELLULITUIS ON RIGHT | 110723,1117807,1148504 | 125409 | 420 | MG | Q3W | ||||||
| 103871087 | 10387108 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | N3609B03P1,N3752B02 | 103792 | 8 | MG/KG | /cycle | |||||||
| 103871087 | 10387108 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSER PRIOR TO SAE 31/MAR/2015?DOSE: 6MG/KG?LAST DOSE PRIOR TO SECOND EPISODE OF SEVERE CELLULI | N3609B03P1,N3752B02 | 103792 | 390 | MG | Q3W | ||||||
| 103871087 | 10387108 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 290 | MG | |||||||||
| 103871087 | 10387108 | 6 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE: 09/JUL/2014 | 0 | 175 | MG | ||||||||
| 103871087 | 10387108 | 7 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | 8 | MG | |||||||||
| 103871087 | 10387108 | 8 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | 8 | MG | |||||||||
| 103871087 | 10387108 | 9 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | 50 | MG | |||||||||
| 103871087 | 10387108 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 0 | 10 | MG | |||||||||
| 103871087 | 10387108 | 11 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | 50 | MG | |||||||||
| 103871087 | 10387108 | 12 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | 4 | MG | |||||||||
| 103871087 | 10387108 | 13 | C | CHLORPHENIRAMINE. | CHLORPHENIRAMINE | 1 | Unknown | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103871087 | 10387108 | 1 | HER-2 positive breast cancer |
| 103871087 | 10387108 | 3 | HER-2 positive breast cancer |
| 103871087 | 10387108 | 5 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103871087 | 10387108 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103871087 | 10387108 | Cellulitis | |
| 103871087 | 10387108 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 103871087 | 10387108 | 1 | 20140505 | 20140505 | 0 | |
| 103871087 | 10387108 | 2 | 20140708 | 0 | ||
| 103871087 | 10387108 | 3 | 20140504 | 0 | ||
| 103871087 | 10387108 | 4 | 20140709 | 0 | ||
| 103871087 | 10387108 | 5 | 20140504 | 0 | ||
| 103871087 | 10387108 | 6 | 20140709 | 0 | ||
| 103871087 | 10387108 | 7 | 20140505 | 0 | ||
| 103871087 | 10387108 | 8 | 20140708 | 20140713 | 0 | |
| 103871087 | 10387108 | 9 | 20140923 | 20140930 | 0 | |
| 103871087 | 10387108 | 10 | 20140923 | 0 | ||
| 103871087 | 10387108 | 11 | 20140505 | 0 | ||
| 103871087 | 10387108 | 12 | 20140505 | 0 | ||
| 103871087 | 10387108 | 13 | 20140505 | 0 |