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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 996938112 | 9969381 | 12 | F | 20130907 | 20160906 | 20140306 | 20160907 | EXP | MY-ROCHE-1282313 | ROCHE | 59.01 | YR | M | Y | 50.00000 | KG | 20160907 | MD | MY | MY |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 996938112 | 9969381 | 1 | PS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | INITIAL DOSE OF 8 MG/KG IV FOLLOWED BY 6 MG/KG IV EVERY 3 WEEKS | 1106554 | 103792 | 448 | MG | SOLUTION FOR INFUSION | Q3W | |||||
| 996938112 | 9969381 | 2 | SS | Trastuzumab | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SERIOUS ADVERSE EVENT: 11/FEB/2014 | 1106554 | 103792 | 300 | MG | SOLUTION FOR INFUSION | Q3W | |||||
| 996938112 | 9969381 | 3 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 20896 | 1650 | MG | BID | ||||||||
| 996938112 | 9969381 | 4 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 20896 | 1650 | MG | BID | ||||||||
| 996938112 | 9969381 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 0 | 128 | MG | Q3W | ||||||||
| 996938112 | 9969381 | 6 | C | ISOPHANE INSULIN | INSULIN NOS | 1 | Subcutaneous | DOSE UNIT=U | 0 | ||||||||||
| 996938112 | 9969381 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 1 | G | TABLET | ||||||||
| 996938112 | 9969381 | 8 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 0 | 160 | MG | |||||||||
| 996938112 | 9969381 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | 4 | MG | |||||||||
| 996938112 | 9969381 | 10 | C | MAXOLON | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 996938112 | 9969381 | 11 | C | MAXOLON | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 996938112 | 9969381 | 12 | C | MAXOLON | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | |||||||||
| 996938112 | 9969381 | 13 | C | MAXOLON | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 996938112 | 9969381 | 14 | C | MAXOLON | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 996938112 | 9969381 | 15 | C | LORATADINE. | LORATADINE | 1 | Oral | FOR RELIEF OF SYMPTOMS ASSOCIATED WITH ALLERGIC RHINITIS EG SNEEZING | 0 | 10 | MG | ||||||||
| 996938112 | 9969381 | 16 | C | LORATADINE. | LORATADINE | 1 | 0 | ||||||||||||
| 996938112 | 9969381 | 17 | C | GRISEOFULVIN. | GRISEOFULVIN | 1 | Oral | INDICATION: ANTIFUNGAL | 0 | 250 | MG | ||||||||
| 996938112 | 9969381 | 18 | C | CEFUROXIME. | CEFUROXIME | 1 | Oral | INDICATION: SKIN AND SOFT-TISSUE INFECTIONS EG, FURUNCULOSIS, PYODERMA AND IMPETIGO | 0 | 500 | MG | ||||||||
| 996938112 | 9969381 | 19 | C | LORATADINE. | LORATADINE | 1 | Oral | INDICATION: RELIEF OF SYMPTOMS ASSOCIATED W/ ALLERGIC RHINITIS EG SNEEZING, NASAL DISCHARGE + ITCHIN | 0 | 10 | MG | ||||||||
| 996938112 | 9969381 | 20 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 0 | 20 | MG | |||||||||
| 996938112 | 9969381 | 21 | C | EMEND | APREPITANT | 1 | Oral | 0 | 125 | MG | |||||||||
| 996938112 | 9969381 | 22 | C | EMEND | APREPITANT | 1 | Oral | 0 | 80 | MG | |||||||||
| 996938112 | 9969381 | 23 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | SELECT IF ONGOING=NO DOSE UNIT=G | 0 | .5 | G | ||||||||
| 996938112 | 9969381 | 24 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | .5 | MG | |||||||||
| 996938112 | 9969381 | 25 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | INDICATION PAIN CONTROLLER | 0 | 1 | G | ||||||||
| 996938112 | 9969381 | 26 | C | CEFUROXIME. | CEFUROXIME | 1 | Oral | FOR SKIN AND SOFT TISSUE INFECTION EG | 0 | 500 | MG | ||||||||
| 996938112 | 9969381 | 27 | C | CEFUROXIME. | CEFUROXIME | 1 | 0 | ||||||||||||
| 996938112 | 9969381 | 28 | C | CEFUROXIME. | CEFUROXIME | 1 | 0 | ||||||||||||
| 996938112 | 9969381 | 29 | SS | Pertuzumab | PERTUZUMAB | 1 | Intravenous (not otherwise specified) | PAK45958,PAK53527 | 115041 | SOLUTION FOR INFUSION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 996938112 | 9969381 | 1 | HER-2 positive gastric cancer |
| 996938112 | 9969381 | 3 | HER-2 positive gastric cancer |
| 996938112 | 9969381 | 5 | HER-2 positive gastric cancer |
| 996938112 | 9969381 | 6 | Diabetes mellitus |
| 996938112 | 9969381 | 7 | Diabetes mellitus |
| 996938112 | 9969381 | 8 | Diabetes mellitus |
| 996938112 | 9969381 | 10 | Dyspepsia |
| 996938112 | 9969381 | 11 | Flatulence |
| 996938112 | 9969381 | 12 | Gastrooesophageal reflux disease |
| 996938112 | 9969381 | 13 | Nausea |
| 996938112 | 9969381 | 14 | Vomiting |
| 996938112 | 9969381 | 15 | Rhinorrhoea |
| 996938112 | 9969381 | 16 | Nasal pruritus |
| 996938112 | 9969381 | 20 | Hypercholesterolaemia |
| 996938112 | 9969381 | 21 | Vomiting |
| 996938112 | 9969381 | 23 | Insomnia |
| 996938112 | 9969381 | 24 | Insomnia |
| 996938112 | 9969381 | 26 | Furuncle |
| 996938112 | 9969381 | 27 | Pyoderma |
| 996938112 | 9969381 | 28 | Impetigo |
| 996938112 | 9969381 | 29 | HER-2 positive gastric cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 996938112 | 9969381 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 996938112 | 9969381 | Dehydration | |
| 996938112 | 9969381 | Diarrhoea |
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 |
|---|---|---|---|---|---|---|
| 996938112 | 9969381 | 1 | 20130902 | 20130902 | 0 | |
| 996938112 | 9969381 | 3 | 20130903 | 20130907 | 0 | |
| 996938112 | 9969381 | 4 | 20130916 | 0 | ||
| 996938112 | 9969381 | 5 | 20130902 | 20130902 | 0 | |
| 996938112 | 9969381 | 6 | 2009 | 0 | ||
| 996938112 | 9969381 | 7 | 1993 | 20140421 | 0 | |
| 996938112 | 9969381 | 8 | 1998 | 0 | ||
| 996938112 | 9969381 | 9 | 20130903 | 20130905 | 0 | |
| 996938112 | 9969381 | 10 | 20130903 | 20130905 | 0 | |
| 996938112 | 9969381 | 11 | 20140228 | 20140302 | 0 | |
| 996938112 | 9969381 | 12 | 20140212 | 20140221 | 0 | |
| 996938112 | 9969381 | 15 | 20130927 | 20131003 | 0 | |
| 996938112 | 9969381 | 17 | 20130927 | 0 | ||
| 996938112 | 9969381 | 18 | 20130927 | 20131003 | 0 | |
| 996938112 | 9969381 | 19 | 20130927 | 20131003 | 0 | |
| 996938112 | 9969381 | 20 | 2009 | 20140421 | 0 | |
| 996938112 | 9969381 | 21 | 20130902 | 20130902 | 0 | |
| 996938112 | 9969381 | 22 | 20130903 | 20130904 | 0 | |
| 996938112 | 9969381 | 23 | 20140223 | 20140224 | 0 | |
| 996938112 | 9969381 | 24 | 20140211 | 20140221 | 0 | |
| 996938112 | 9969381 | 25 | 20140212 | 20140221 | 0 | |
| 996938112 | 9969381 | 26 | 20130927 | 20131003 | 0 | |
| 996938112 | 9969381 | 29 | 20130902 | 20140211 | 0 |