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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1206312511 | 12063125 | 11 | F | 20141206 | 20160825 | 20160210 | 20160826 | EXP | BR-ROCHE-1507252 | ROCHE | 64.22 | YR | M | Y | 62.00000 | KG | 20160826 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1206312511 | 12063125 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE?MOST RECENT DOSE ON 24/NOV/2014 (528 MG) | N | 1106554 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | ||||
| 1206312511 | 12063125 | 2 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | MOST RECENT DOSE ON 06/DEC/2014 AT 1750MG.?MOST RECENT DOSE ON 08/DEC/2014 AT 1750MG. | N | X3293B01 | 20896 | 1000 | MG/M**2 | TABLET | BID | ||||
| 1206312511 | 12063125 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE ON 24/NOV/2014. | N | 0 | 143.2 | MG | Q3W | ||||||
| 1206312511 | 12063125 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | |||||||||
| 1206312511 | 12063125 | 5 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG | |||||||||
| 1206312511 | 12063125 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | 4 | MG | |||||||||
| 1206312511 | 12063125 | 7 | C | VONAU | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 0 | 8 | MG | |||||||||
| 1206312511 | 12063125 | 8 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 10 | MG | |||||||||
| 1206312511 | 12063125 | 9 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | 0 | ||||||||||||
| 1206312511 | 12063125 | 10 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1206312511 | 12063125 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 1206312511 | 12063125 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 0 | 2 | MG | |||||||||
| 1206312511 | 12063125 | 13 | C | DIPYRONE | DIPYRONE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | |||||||||
| 1206312511 | 12063125 | 14 | C | SALINE | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | INDICATION: HYDRATION | 0 | ||||||||||
| 1206312511 | 12063125 | 15 | C | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | |||||||||
| 1206312511 | 12063125 | 16 | C | HYOSCINE | SCOPOLAMINE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1206312511 | 12063125 | 17 | C | RANITIDINE. | RANITIDINE | 1 | Oral | INDICATION: PROPHYLAXIS GASTRITIS | 0 | 15 | MG | ||||||||
| 1206312511 | 12063125 | 18 | C | NYSTATIN. | NYSTATIN | 1 | Oral | 0 | 100 | IU | |||||||||
| 1206312511 | 12063125 | 19 | C | NYSTATIN. | NYSTATIN | 1 | Oral | 0 | 100 | IU | |||||||||
| 1206312511 | 12063125 | 20 | C | NYSTATIN. | NYSTATIN | 1 | Oral | 0 | 100 | IU | |||||||||
| 1206312511 | 12063125 | 21 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | N | PAK05071 | 0 | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1206312511 | 12063125 | 1 | HER-2 positive gastric cancer |
| 1206312511 | 12063125 | 2 | HER-2 positive gastric cancer |
| 1206312511 | 12063125 | 3 | HER-2 positive gastric cancer |
| 1206312511 | 12063125 | 4 | Prophylaxis against gastrointestinal ulcer |
| 1206312511 | 12063125 | 5 | Depression |
| 1206312511 | 12063125 | 6 | Prophylaxis of nausea and vomiting |
| 1206312511 | 12063125 | 7 | Prophylaxis of nausea and vomiting |
| 1206312511 | 12063125 | 8 | Nausea |
| 1206312511 | 12063125 | 9 | Vomiting |
| 1206312511 | 12063125 | 10 | Pain |
| 1206312511 | 12063125 | 11 | Pyrexia |
| 1206312511 | 12063125 | 12 | Insomnia |
| 1206312511 | 12063125 | 13 | Pain |
| 1206312511 | 12063125 | 15 | Vomiting |
| 1206312511 | 12063125 | 16 | Abdominal pain |
| 1206312511 | 12063125 | 18 | Mucosal inflammation |
| 1206312511 | 12063125 | 21 | HER-2 positive gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1206312511 | 12063125 | DE |
| 1206312511 | 12063125 | DS |
| 1206312511 | 12063125 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1206312511 | 12063125 | Diarrhoea | |
| 1206312511 | 12063125 | Febrile neutropenia | |
| 1206312511 | 12063125 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 1206312511 | 12063125 | 1 | 20141124 | 0 | ||
| 1206312511 | 12063125 | 2 | 20141124 | 0 | ||
| 1206312511 | 12063125 | 3 | 20141124 | 0 | ||
| 1206312511 | 12063125 | 4 | 201207 | 0 | ||
| 1206312511 | 12063125 | 5 | 20141117 | 0 | ||
| 1206312511 | 12063125 | 6 | 20141125 | 20141127 | 0 | |
| 1206312511 | 12063125 | 7 | 20141125 | 20141127 | 0 | |
| 1206312511 | 12063125 | 8 | 20141210 | 20141210 | 0 | |
| 1206312511 | 12063125 | 10 | 20141210 | 20141210 | 0 | |
| 1206312511 | 12063125 | 12 | 20141210 | 20141211 | 0 | |
| 1206312511 | 12063125 | 13 | 20141210 | 20141210 | 0 | |
| 1206312511 | 12063125 | 14 | 20141210 | 20141211 | 0 | |
| 1206312511 | 12063125 | 15 | 20141211 | 20141211 | 0 | |
| 1206312511 | 12063125 | 16 | 20141211 | 20141211 | 0 | |
| 1206312511 | 12063125 | 17 | 20141211 | 20141211 | 0 | |
| 1206312511 | 12063125 | 18 | 20141211 | 20141211 | 0 | |
| 1206312511 | 12063125 | 19 | 20141126 | 20141129 | 0 | |
| 1206312511 | 12063125 | 20 | 20141206 | 20141211 | 0 | |
| 1206312511 | 12063125 | 21 | 20141124 | 0 |