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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1195195012 | 11951950 | 12 | F | 20151205 | 20160922 | 20160126 | 20160923 | EXP | CN-ROCHE-1676474 | ROCHE | 61.07 | YR | F | Y | 50.00000 | KG | 20160923 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1195195012 | 11951950 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE | N | 1145091 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||
| 1195195012 | 11951950 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTAINCE DOSE; MOST RECENT DOSE PRIOR TO THE EVENT ON 20/NOV/2015 | N | 1145091 | 103792 | 300 | MG | SOLUTION FOR INFUSION | Q3W | ||||
| 1195195012 | 11951950 | 3 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | MOST RECENT DOSE PRIOR TO THE EVENT ON 04/DEC/2015 | N | 20896 | 1500 | MG | TABLET | BID | |||||
| 1195195012 | 11951950 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR TO THE EVENT ON 20/NOV/2015 | N | 0 | 122 | MG | Q3W | ||||||
| 1195195012 | 11951950 | 5 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Intravenous (not otherwise specified) | 0 | 30 | MG | |||||||||
| 1195195012 | 11951950 | 6 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | 0 | ||||||||||||
| 1195195012 | 11951950 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 10 | MG | |||||||||
| 1195195012 | 11951950 | 8 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intramuscular | 0 | 20 | MG | |||||||||
| 1195195012 | 11951950 | 9 | C | PALONOSETRON | PALONOSETRON | 1 | Intravenous (not otherwise specified) | 0 | .25 | MG | |||||||||
| 1195195012 | 11951950 | 10 | C | PALONOSETRON | PALONOSETRON | 1 | 0 | ||||||||||||
| 1195195012 | 11951950 | 11 | C | KCL | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | INDICATION - INTRAVENOUS HYPERALIMENTATION | 0 | 3 | G | ||||||||
| 1195195012 | 11951950 | 12 | C | KCL | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | INDICATION - INTRAVENOUS HYPERALIMENTATION | 0 | 2 | G | ||||||||
| 1195195012 | 11951950 | 13 | C | CREATINE PHOSPHATE SODIUM | CREATINE | 1 | Intravenous (not otherwise specified) | INDICATION - INTRAVENOUS HYPERALIMENTATION | 0 | 2 | G | ||||||||
| 1195195012 | 11951950 | 14 | C | VITAMIN C | ASCORBIC ACID | 1 | Intravenous (not otherwise specified) | INDICATION - INTRAVENOUS HYPERALIMENTATION | 0 | 2000 | MG | ||||||||
| 1195195012 | 11951950 | 15 | C | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | INDICATION - INTRAVENOUS HYPERALIMENTATION | 0 | .2 | G | ||||||||
| 1195195012 | 11951950 | 16 | C | ESOMEPRAZOLE SODIUM. | ESOMEPRAZOLE SODIUM | 1 | Intravenous (not otherwise specified) | INDICATION - TO PROTECT THE STOMACH | 0 | 40 | MG | ||||||||
| 1195195012 | 11951950 | 17 | C | APREPITANT. | APREPITANT | 1 | Oral | 0 | 125 | MG | |||||||||
| 1195195012 | 11951950 | 18 | C | APREPITANT. | APREPITANT | 1 | 0 | ||||||||||||
| 1195195012 | 11951950 | 19 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Oral | 0 | 1 | G | |||||||||
| 1195195012 | 11951950 | 20 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1195195012 | 11951950 | 21 | C | MEGESTROL | MEGESTROL | 1 | Oral | INDICATION: IMPROVE THE APPETITE | 0 | 160 | MG | ||||||||
| 1195195012 | 11951950 | 22 | C | BERBERINE | BERBERINE | 1 | Oral | 0 | 30 | MG | |||||||||
| 1195195012 | 11951950 | 23 | C | SMECTITE | MONTMORILLONITE | 1 | Oral | 0 | 3 | G | |||||||||
| 1195195012 | 11951950 | 24 | C | SMECTITE | MONTMORILLONITE | 1 | Unknown | 0 | |||||||||||
| 1195195012 | 11951950 | 25 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR TO THE EVENT ON 20/NOV/2015 | N | PAK85288 | 0 | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1195195012 | 11951950 | 1 | HER-2 positive gastric cancer |
| 1195195012 | 11951950 | 3 | HER-2 positive gastric cancer |
| 1195195012 | 11951950 | 4 | HER-2 positive gastric cancer |
| 1195195012 | 11951950 | 5 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 6 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 7 | Allergy prophylaxis |
| 1195195012 | 11951950 | 8 | Allergy prophylaxis |
| 1195195012 | 11951950 | 9 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 10 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 17 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 18 | Prophylaxis of nausea and vomiting |
| 1195195012 | 11951950 | 19 | Hypokalaemia |
| 1195195012 | 11951950 | 20 | Polyuria |
| 1195195012 | 11951950 | 22 | Diarrhoea |
| 1195195012 | 11951950 | 23 | Diarrhoea |
| 1195195012 | 11951950 | 25 | HER-2 positive gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1195195012 | 11951950 | LT |
| 1195195012 | 11951950 | HO |
| 1195195012 | 11951950 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1195195012 | 11951950 | Acute respiratory distress syndrome | |
| 1195195012 | 11951950 | Gastroenteritis | |
| 1195195012 | 11951950 | Gastrointestinal haemorrhage | |
| 1195195012 | 11951950 | Multiple organ dysfunction syndrome | |
| 1195195012 | 11951950 | Pneumonia | |
| 1195195012 | 11951950 | 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 |
|---|---|---|---|---|---|---|
| 1195195012 | 11951950 | 1 | 20151027 | 20151027 | 0 | |
| 1195195012 | 11951950 | 3 | 20151027 | 0 | ||
| 1195195012 | 11951950 | 4 | 20151027 | 0 | ||
| 1195195012 | 11951950 | 5 | 20151027 | 20151120 | 0 | |
| 1195195012 | 11951950 | 7 | 20151027 | 20151121 | 0 | |
| 1195195012 | 11951950 | 8 | 20151027 | 20151120 | 0 | |
| 1195195012 | 11951950 | 9 | 20151027 | 20151121 | 0 | |
| 1195195012 | 11951950 | 11 | 20151116 | 20151118 | 0 | |
| 1195195012 | 11951950 | 12 | 20151026 | 20151121 | 0 | |
| 1195195012 | 11951950 | 13 | 20151026 | 20151121 | 0 | |
| 1195195012 | 11951950 | 14 | 20151026 | 20151121 | 0 | |
| 1195195012 | 11951950 | 15 | 20151026 | 20151121 | 0 | |
| 1195195012 | 11951950 | 16 | 20151028 | 20151121 | 0 | |
| 1195195012 | 11951950 | 17 | 20151027 | 20151122 | 0 | |
| 1195195012 | 11951950 | 19 | 20151118 | 20151121 | 0 | |
| 1195195012 | 11951950 | 20 | 20151120 | 20151120 | 0 | |
| 1195195012 | 11951950 | 21 | 20151113 | 20151116 | 0 | |
| 1195195012 | 11951950 | 22 | 20151117 | 2015 | 0 | |
| 1195195012 | 11951950 | 23 | 20151113 | 2015 | 0 | |
| 1195195012 | 11951950 | 24 | 20151205 | 0 | ||
| 1195195012 | 11951950 | 25 | 20151027 | 0 |