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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114165837 | 11416583 | 7 | F | 20150812 | 20160913 | 20150825 | 20160915 | EXP | US-ROCHE-1622333 | ROCHE | 46.69 | YR | F | Y | 70.20000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114165837 | 11416583 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE AS PER PROTOCOL | Y | 1149252 | 9900 | 840 | MG | SOLUTION FOR INFUSION | 1X | ||||
| 114165837 | 11416583 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINENCE DOSE?DATE OF MOST RECENT DOSE PRIOR TO AE ONSET: 11/AUG/2015 | Y | 1149252 | 9900 | 420 | MG | SOLUTION FOR INFUSION | Q3W | ||||
| 114165837 | 11416583 | 3 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE AS PER PROTOCOL | Y | 1146819 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | ||||
| 114165837 | 11416583 | 4 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINENCE DOSE?DATE OF MOST RECENT DOSE 11/AUG/2015 | Y | 1146819 | 103792 | 440 | MG | SOLUTION FOR INFUSION | Q3W | ||||
| 114165837 | 11416583 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE 11/AUG/2015 | Y | 0 | 141 | MG | |||||||
| 114165837 | 11416583 | 6 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | LAST DOSE ADMINISTERED: 90 MG, DATE OF LAST DOSE PRIOR TO SAE: 26/MAY/2015 | U | 0 | |||||||||
| 114165837 | 11416583 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 114165837 | 11416583 | 8 | C | EMEND | APREPITANT | 1 | Intravenous (not otherwise specified) | INDICATION: PRE-CHEMO | 0 | 150 | MG | ||||||||
| 114165837 | 11416583 | 9 | C | EMLA | LIDOCAINEPRILOCAINE | 1 | Topical | 0 | 2.5 | PCT | |||||||||
| 114165837 | 11416583 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | INDICATION: PRE-CHEMO | 0 | 16 | MG | ||||||||
| 114165837 | 11416583 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 0 | 8 | MG | |||||||||
| 114165837 | 11416583 | 12 | C | DECADRON | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | INDICATION: PRE-CHEMO | 0 | 12 | MG | ||||||||
| 114165837 | 11416583 | 13 | C | DECADRON | DEXAMETHASONE | 1 | Oral | POST CHEMO DAY 1 THROUGH DAY 5 | 0 | 4 | MG | ||||||||
| 114165837 | 11416583 | 14 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | Oral | INDICATION: POST-CHEMO | 0 | 10 | MG | ||||||||
| 114165837 | 11416583 | 15 | C | EXCEDRIN (UNITED STATES) | 2 | Oral | 0 | ||||||||||||
| 114165837 | 11416583 | 16 | C | DOCUSATE-SENNA | 2 | Oral | 0 | 50 | MG | ||||||||||
| 114165837 | 11416583 | 17 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 5 | MG | |||||||||
| 114165837 | 11416583 | 18 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | |||||||||
| 114165837 | 11416583 | 19 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 5 | MG | |||||||||
| 114165837 | 11416583 | 20 | C | ATIVAN ORAL | 2 | Oral | 0 | .5 | MG | ||||||||||
| 114165837 | 11416583 | 21 | C | POLYETHYLENE GLYCOL 3350. | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 0 | 17 | G | |||||||||
| 114165837 | 11416583 | 22 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 5 | MG | TABLET | ||||||||
| 114165837 | 11416583 | 23 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114165837 | 11416583 | 1 | HER-2 positive breast cancer |
| 114165837 | 11416583 | 3 | HER-2 positive breast cancer |
| 114165837 | 11416583 | 5 | HER-2 positive breast cancer |
| 114165837 | 11416583 | 6 | HER-2 positive breast cancer |
| 114165837 | 11416583 | 7 | HER-2 positive breast cancer |
| 114165837 | 11416583 | 9 | Premedication |
| 114165837 | 11416583 | 15 | Tension headache |
| 114165837 | 11416583 | 16 | Constipation |
| 114165837 | 11416583 | 17 | Mucosal inflammation |
| 114165837 | 11416583 | 18 | Pyrexia |
| 114165837 | 11416583 | 19 | Insomnia |
| 114165837 | 11416583 | 20 | Anxiety |
| 114165837 | 11416583 | 21 | Constipation |
| 114165837 | 11416583 | 22 | Pain |
| 114165837 | 11416583 | 23 | Genital herpes |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114165837 | 11416583 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114165837 | 11416583 | Pneumonitis |
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 |
|---|---|---|---|---|---|---|
| 114165837 | 11416583 | 1 | 20150609 | 20150609 | 0 | |
| 114165837 | 11416583 | 3 | 20150609 | 20150609 | 0 | |
| 114165837 | 11416583 | 5 | 20150609 | 0 | ||
| 114165837 | 11416583 | 6 | 20150414 | 0 | ||
| 114165837 | 11416583 | 7 | 20150414 | 0 | ||
| 114165837 | 11416583 | 8 | 20150414 | 0 | ||
| 114165837 | 11416583 | 9 | 20150414 | 0 | ||
| 114165837 | 11416583 | 10 | 20150414 | 0 | ||
| 114165837 | 11416583 | 11 | 20150414 | 0 | ||
| 114165837 | 11416583 | 12 | 20150414 | 0 | ||
| 114165837 | 11416583 | 13 | 20150414 | 0 | ||
| 114165837 | 11416583 | 14 | 20150414 | 0 | ||
| 114165837 | 11416583 | 15 | 20150512 | 0 | ||
| 114165837 | 11416583 | 16 | 20150512 | 0 | ||
| 114165837 | 11416583 | 17 | 20150526 | 0 | ||
| 114165837 | 11416583 | 18 | 20150519 | 0 | ||
| 114165837 | 11416583 | 19 | 20150428 | 0 | ||
| 114165837 | 11416583 | 20 | 20150428 | 0 | ||
| 114165837 | 11416583 | 21 | 20150521 | 0 | ||
| 114165837 | 11416583 | 22 | 20150521 | 0 | ||
| 114165837 | 11416583 | 23 | 20150725 | 0 |