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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1058093513 | 10580935 | 13 | F | 20141015 | 20160725 | 20141113 | 20160727 | EXP | MX-ROCHE-1490099 | ROCHE | 71.00 | YR | F | Y | 0.00000 | 20160727 | MD | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1058093513 | 10580935 | 1 | PS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | 1125805 | 125409 | 840 | MG | ||||||||
| 1058093513 | 10580935 | 2 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | TEMPORARILY INTERRUPTED | 1125805 | 125409 | 420 | MG | Q3W | ||||||
| 1058093513 | 10580935 | 3 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 04/SEP/2014 | 1125805 | 125409 | 420 | MG | Q3W | ||||||
| 1058093513 | 10580935 | 4 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 24/SEP/2014 | 1125805 | 125409 | 420 | MG | Q3W | ||||||
| 1058093513 | 10580935 | 5 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | ||||||||
| 1058093513 | 10580935 | 6 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6MG/KG?LAST DOSE PRIOR TO SAE 24/SEP/2014 | 103792 | 360 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 1058093513 | 10580935 | 7 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 04/SEP/2014 | 103792 | 360 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 1058093513 | 10580935 | 8 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 26/SEP/2014. | 103792 | 360 | MG | SOLUTION FOR INFUSION | Q3W | ||||||
| 1058093513 | 10580935 | 9 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | DOSE: 120MG | 0 | 75 | MG/M**2 | Q3W | |||||||
| 1058093513 | 10580935 | 10 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 24/SEP/2014, DOSE: 95MG | 0 | 75 | MG/M**2 | Q3W | |||||||
| 1058093513 | 10580935 | 11 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 04/SEP/2014 | 0 | 95 | MG | Q3W | |||||||
| 1058093513 | 10580935 | 12 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE 26/SEP/2014 | 0 | 95 | MG | Q3W | |||||||
| 1058093513 | 10580935 | 13 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | 8 | MG | |||||||||
| 1058093513 | 10580935 | 14 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | 8 | MG | |||||||||
| 1058093513 | 10580935 | 15 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | 50 | MG | |||||||||
| 1058093513 | 10580935 | 16 | C | CHLORPHENIRAMINE. | CHLORPHENIRAMINE | 1 | Unknown | 0 | 10 | MG | |||||||||
| 1058093513 | 10580935 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 20 | MG | |||||||||
| 1058093513 | 10580935 | 18 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | 0 | 1750 | MG | |||||||||
| 1058093513 | 10580935 | 19 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | 1500 | MG | |||||||||
| 1058093513 | 10580935 | 20 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | 1 | G | |||||||||
| 1058093513 | 10580935 | 21 | C | Filgrastim | FILGRASTIM | 1 | Unknown | 0 | 300 | UG | |||||||||
| 1058093513 | 10580935 | 22 | C | Filgrastim | FILGRASTIM | 1 | Unknown | 0 | 300 | UG | |||||||||
| 1058093513 | 10580935 | 23 | C | CEFTAZIDIME. | CEFTAZIDIME | 1 | Unknown | 0 | 3 | G | |||||||||
| 1058093513 | 10580935 | 24 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | Unknown | 0 | 1500 | MG | |||||||||
| 1058093513 | 10580935 | 25 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 40 | MG | |||||||||
| 1058093513 | 10580935 | 26 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 20 | MG | |||||||||
| 1058093513 | 10580935 | 27 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 40 | MG | |||||||||
| 1058093513 | 10580935 | 28 | C | TRADOL | TRAMADOL HYDROCHLORIDE | 1 | Unknown | 0 | 50 | MG | |||||||||
| 1058093513 | 10580935 | 29 | C | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | 0 | 4 | MG | |||||||||
| 1058093513 | 10580935 | 30 | C | LOPERAMIDE | LOPERAMIDE | 1 | Unknown | 0 | 3 | MG | |||||||||
| 1058093513 | 10580935 | 31 | C | BUTYLHYOSCINE | 2 | Unknown | 0 | 30 | MG | ||||||||||
| 1058093513 | 10580935 | 32 | C | BUTYLHYOSCINE | 2 | Unknown | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1058093513 | 10580935 | 1 | HER-2 positive breast cancer |
| 1058093513 | 10580935 | 5 | HER-2 positive breast cancer |
| 1058093513 | 10580935 | 9 | HER-2 positive breast cancer |
| 1058093513 | 10580935 | 29 | Diarrhoea |
| 1058093513 | 10580935 | 31 | Abdominal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1058093513 | 10580935 | DE |
| 1058093513 | 10580935 | LT |
| 1058093513 | 10580935 | HO |
| 1058093513 | 10580935 | OT |
| 1058093513 | 10580935 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1058093513 | 10580935 | Aspartate aminotransferase increased | |
| 1058093513 | 10580935 | Blood bilirubin increased | |
| 1058093513 | 10580935 | Cholecystitis | |
| 1058093513 | 10580935 | 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 |
|---|---|---|---|---|---|---|
| 1058093513 | 10580935 | 1 | 20140722 | 20140722 | 0 | |
| 1058093513 | 10580935 | 2 | 20140814 | 0 | ||
| 1058093513 | 10580935 | 3 | 20140904 | 0 | ||
| 1058093513 | 10580935 | 4 | 20140924 | 0 | ||
| 1058093513 | 10580935 | 5 | 20140722 | 20140722 | 0 | |
| 1058093513 | 10580935 | 6 | 20140814 | 0 | ||
| 1058093513 | 10580935 | 7 | 20140904 | 0 | ||
| 1058093513 | 10580935 | 8 | 20140926 | 0 | ||
| 1058093513 | 10580935 | 9 | 20140722 | 20140722 | 0 | |
| 1058093513 | 10580935 | 10 | 20140814 | 0 | ||
| 1058093513 | 10580935 | 11 | 20140904 | 0 | ||
| 1058093513 | 10580935 | 12 | 20140926 | 0 | ||
| 1058093513 | 10580935 | 13 | 20140722 | 0 | ||
| 1058093513 | 10580935 | 14 | 20140722 | 0 | ||
| 1058093513 | 10580935 | 15 | 20140722 | 0 | ||
| 1058093513 | 10580935 | 16 | 20140722 | 0 | ||
| 1058093513 | 10580935 | 17 | 20140722 | 0 | ||
| 1058093513 | 10580935 | 18 | 20140722 | 20140729 | 0 | |
| 1058093513 | 10580935 | 19 | 20140722 | 20140725 | 0 | |
| 1058093513 | 10580935 | 20 | 20140729 | 20140729 | 0 | |
| 1058093513 | 10580935 | 21 | 20140729 | 20140731 | 0 | |
| 1058093513 | 10580935 | 22 | 20140821 | 0 | ||
| 1058093513 | 10580935 | 23 | 20140729 | 20140801 | 0 | |
| 1058093513 | 10580935 | 24 | 20140729 | 20140801 | 0 | |
| 1058093513 | 10580935 | 25 | 20140730 | 20140801 | 0 | |
| 1058093513 | 10580935 | 26 | 20140821 | 20140828 | 0 | |
| 1058093513 | 10580935 | 27 | 20141030 | 20141121 | 0 | |
| 1058093513 | 10580935 | 28 | 20140730 | 20140730 | 0 | |
| 1058093513 | 10580935 | 29 | 20140817 | 20140820 | 0 | |
| 1058093513 | 10580935 | 30 | 20140817 | 0 | ||
| 1058093513 | 10580935 | 31 | 20140817 | 20140820 | 0 | |
| 1058093513 | 10580935 | 32 | 20140729 | 20140731 | 0 |