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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124639156 | 12463915 | 6 | F | 20160603 | 20160809 | 20160614 | 20160812 | EXP | CN-ROCHE-1770209 | ROCHE | 48.11 | YR | F | Y | 49.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124639156 | 12463915 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LOADING DOSE?DATE OF MOST RECENT DOSE OF TRASTUZUMAB PRIOR TO AE ONSET-18/MAY/2016 | 1145091 | 103792 | 8 | MG/KG | SOLUTION FOR INFUSION | 1X | |||||
| 124639156 | 12463915 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | MAINTENANCE DOSE?DOSE OF LAST TRASTUZUMAB ADMINISTERED- 294 MG | 1145091 | 103792 | 6 | MG/KG | SOLUTION FOR INFUSION | Q3W | |||||
| 124639156 | 12463915 | 3 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | DATE OF MOST RECENT DOSE OF CAPECITABINE PRIOR TO AE ONSET-30/MAY/2016?DOSE OF LAST CAPECITABINE ADM | X3229X1 | 20896 | 1000 | MG/M**2 | TABLET | BID | |||||
| 124639156 | 12463915 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE OF CISPLATIN PRIOR TO AE ONSET-15/JAN/2016.?DOSE OF LAST CISPLATIN ADMINIST | U | 0 | 80 | MG/M**2 | Q3W | ||||||
| 124639156 | 12463915 | 5 | C | DIAMMONIUM GLYCYRRHIZINATE | HERBALS | 1 | Oral | 0 | 150 | MG | |||||||||
| 124639156 | 12463915 | 6 | C | CHLORPHENAMINE MALEATE | CHLORPHENIRAMINE MALEATE | 1 | Oral | 0 | 4 | MG | |||||||||
| 124639156 | 12463915 | 7 | C | ESTAZOLAM. | ESTAZOLAM | 1 | Oral | 0 | 2 | MG | TABLET | ||||||||
| 124639156 | 12463915 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 5 | MG | |||||||||
| 124639156 | 12463915 | 9 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 124639156 | 12463915 | 10 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 124639156 | 12463915 | 11 | C | GLUTATHIONE SODIUM | GLUTATHIONE | 1 | Intravenous (not otherwise specified) | REPORTED AS REDUCED GLUTATHIONE SODIUM?INDICAITON: HEPATOPROTECTION | 0 | 1.2 | G | ||||||||
| 124639156 | 12463915 | 12 | C | ADEMETIONINE 1,4-BUTANEDISULFONATE | 2 | Intravenous (not otherwise specified) | INDICATION: LIVER PROTECTION | 0 | 1 | G | |||||||||
| 124639156 | 12463915 | 13 | C | MAGNESIUM ISOGLYCYRRHIZINATE | MAGNESIUM ISOGLYCYRRHIZINATE | 1 | Intravenous (not otherwise specified) | INDICATION: IMPROVE LIVER FUNCTION | 0 | 150 | MG | ||||||||
| 124639156 | 12463915 | 14 | C | AMINO ACID | 2 | Intravenous (not otherwise specified) | REPORTED AS COMPOUND AMINO ACID?INDICAITON: NUTRITION SUPPORT | 0 | 21.25 | G | |||||||||
| 124639156 | 12463915 | 15 | C | VITAMIN C | ASCORBIC ACID | 1 | Intravenous (not otherwise specified) | INDICATION: NUTRITION SUPPORT | 0 | 3 | G | ||||||||
| 124639156 | 12463915 | 16 | C | VITAMIN B6 | PYRIDOXINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | .2 | G | |||||||||
| 124639156 | 12463915 | 17 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE OF PERTUZUMAB/PLACEBO PRIOR TO AE ONSET-15 MAY 2016 | PAK55876 | 125409 | 840 | MG | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124639156 | 12463915 | 1 | HER-2 positive gastric cancer |
| 124639156 | 12463915 | 3 | HER-2 positive gastric cancer |
| 124639156 | 12463915 | 4 | HER-2 positive gastric cancer |
| 124639156 | 12463915 | 7 | Insomnia |
| 124639156 | 12463915 | 17 | HER-2 positive gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124639156 | 12463915 | DE |
| 124639156 | 12463915 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124639156 | 12463915 | 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 |
|---|---|---|---|---|---|---|
| 124639156 | 12463915 | 1 | 20151001 | 0 | ||
| 124639156 | 12463915 | 3 | 20151001 | 0 | ||
| 124639156 | 12463915 | 4 | 20151001 | 0 | ||
| 124639156 | 12463915 | 5 | 20150921 | 201509 | 0 | |
| 124639156 | 12463915 | 6 | 20150921 | 201509 | 0 | |
| 124639156 | 12463915 | 7 | 20151008 | 0 | ||
| 124639156 | 12463915 | 8 | 20160518 | 20160518 | 0 | |
| 124639156 | 12463915 | 9 | 20160518 | 20160518 | 0 | |
| 124639156 | 12463915 | 10 | 20160518 | 20160518 | 0 | |
| 124639156 | 12463915 | 11 | 20160604 | 20160608 | 0 | |
| 124639156 | 12463915 | 12 | 20160604 | 20160613 | 0 | |
| 124639156 | 12463915 | 13 | 20160608 | 20160613 | 0 | |
| 124639156 | 12463915 | 14 | 20160608 | 20160613 | 0 | |
| 124639156 | 12463915 | 15 | 20160608 | 20160613 | 0 | |
| 124639156 | 12463915 | 16 | 20160608 | 20160613 | 0 | |
| 124639156 | 12463915 | 17 | 20151001 | 0 |