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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124280523 | 12428052 | 3 | F | 20151202 | 20160708 | 20160602 | 20160713 | EXP | US-ROCHE-1672713 | ROCHE | 69.35 | YR | F | Y | 70.50000 | KG | 20160713 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124280523 | 12428052 | 1 | PS | Atezolizumab | ATEZOLIZUMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR TO SERIOUS ADVERSE EVENT ON 12/NOV/2015 (PRIOR TO DIARRHEA), 28/DEC/2015 (PRI | U | 1149125 | 761034 | 1200 | MG | INFUSION | Q3W | ||||
| 124280523 | 12428052 | 2 | SS | NAB-Paclitaxel | PACLITAXEL | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO THE SAE: 28/DEC/2015 (PRIOR TO MEDICATION RELATED COLITIS), 21/JAN/2016 (PRIOR T | U | 1148964 | 0 | 120 | MG | INFUSION | Q3W | ||||
| 124280523 | 12428052 | 3 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE PRIOR TO SERIOUS ADVERSE EVENT 369 MG, ON 24/SEP/2015 (PRIOR TO DIARRHEA, CLOSTRIDI | U | 0 | INFUSION | ||||||||
| 124280523 | 12428052 | 4 | C | MENTHOL/ZINC OXIDE | MENTHOLINC OXIDE | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 5 | C | COZAAR | LOSARTAN POTASSIUM | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 6 | C | LOPRESSOR | METOPROLOL TARTRATE | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 7 | C | NICODERM CQ | NICOTINE | 1 | Unknown | PATCH | 0 | ||||||||||
| 124280523 | 12428052 | 8 | C | NISOLDIPINE. | NISOLDIPINE | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 9 | C | ZOCOR | SIMVASTATIN | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 10 | C | PRESERVISION | MINERALSVITAMINS | 1 | Unknown | VISION SUPPLEMENT | 0 | ||||||||||
| 124280523 | 12428052 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | SUPPLEMENT | 0 | ||||||||||
| 124280523 | 12428052 | 12 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | SUPPLEMENT | 0 | ||||||||||
| 124280523 | 12428052 | 13 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | NAUSEA/VOMITING PREVENTION | 0 | ||||||||||
| 124280523 | 12428052 | 14 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 15 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 16 | C | FENOFIBRATE. | FENOFIBRATE | 1 | 0 | ||||||||||||
| 124280523 | 12428052 | 17 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 18 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 19 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | INDICATION: STOMACH ACID | 0 | ||||||||||
| 124280523 | 12428052 | 20 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 21 | C | PEPCID | FAMOTIDINE | 1 | Unknown | 0 | |||||||||||
| 124280523 | 12428052 | 22 | C | MENTHOL/ZINC OXIDE | MENTHOLINC OXIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124280523 | 12428052 | 1 | Non-small cell lung cancer |
| 124280523 | 12428052 | 2 | Non-small cell lung cancer |
| 124280523 | 12428052 | 3 | Non-small cell lung cancer |
| 124280523 | 12428052 | 4 | Dermatitis |
| 124280523 | 12428052 | 5 | Hypertension |
| 124280523 | 12428052 | 6 | Hypertension |
| 124280523 | 12428052 | 7 | Ex-tobacco user |
| 124280523 | 12428052 | 8 | Hypertension |
| 124280523 | 12428052 | 9 | Blood cholesterol increased |
| 124280523 | 12428052 | 14 | Nausea |
| 124280523 | 12428052 | 15 | Vomiting |
| 124280523 | 12428052 | 16 | Blood cholesterol increased |
| 124280523 | 12428052 | 17 | Depression |
| 124280523 | 12428052 | 18 | Urinary tract infection |
| 124280523 | 12428052 | 20 | Pain |
| 124280523 | 12428052 | 21 | Dyspepsia |
| 124280523 | 12428052 | 22 | Dermatitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124280523 | 12428052 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124280523 | 12428052 | Clostridium difficile colitis | |
| 124280523 | 12428052 | Colitis | |
| 124280523 | 12428052 | 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 |
|---|---|---|---|---|---|---|
| 124280523 | 12428052 | 1 | 20150827 | 0 | ||
| 124280523 | 12428052 | 2 | 20150827 | 0 | ||
| 124280523 | 12428052 | 3 | 20150827 | 0 | ||
| 124280523 | 12428052 | 4 | 20150830 | 0 | ||
| 124280523 | 12428052 | 7 | 201506 | 0 | ||
| 124280523 | 12428052 | 11 | 20150730 | 0 | ||
| 124280523 | 12428052 | 12 | 20150810 | 0 | ||
| 124280523 | 12428052 | 13 | 20150810 | 0 | ||
| 124280523 | 12428052 | 14 | 20150827 | 0 | ||
| 124280523 | 12428052 | 17 | 20150915 | 0 | ||
| 124280523 | 12428052 | 18 | 20160107 | 20160114 | 0 | |
| 124280523 | 12428052 | 19 | 20150830 | 0 | ||
| 124280523 | 12428052 | 20 | 20150830 | 0 | ||
| 124280523 | 12428052 | 21 | 20160128 | 0 | ||
| 124280523 | 12428052 | 22 | 20150830 | 0 |