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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126478073 | 12647807 | 3 | F | 20160509 | 20160831 | 20160812 | 20160903 | EXP | ES-ROCHE-1778645 | ROCHE | 74.61 | YR | M | Y | 60.20000 | KG | 20160903 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126478073 | 12647807 | 1 | PS | Atezolizumab | ATEZOLIZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF THE MOST RECENT DOSE PRIOR TO THE FIRST EPISODE OF PNEUMONITIS: 18/APR/2016 | Y | 1149126,1149754 | 761034 | 1200 | MG | Q3W | |||||
| 126478073 | 12647807 | 2 | SS | Atezolizumab | ATEZOLIZUMAB | 1 | Intravenous (not otherwise specified) | REINTRODUCTION DOSE.?DATE OF THE MOST RECENT DOSE PRIOR TO THE SECOND EPISODE OF PNEUMONITIS: 06/JUN | Y | 1149126,1149754 | 761034 | 1200 | MG | Q3W | |||||
| 126478073 | 12647807 | 3 | SS | Atezolizumab | ATEZOLIZUMAB | 1 | Intravenous (not otherwise specified) | REINTRODUCTION DOSE.?DATE OF THE MOST RECENT DOSE PRIOR TO RESPIRATORY INSUFFICIENCY: 02/JUL/2016 | Y | 1149126,1149754 | 761034 | 1200 | MG | Q3W | |||||
| 126478073 | 12647807 | 4 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC=6 (DOSAGE TAKEN FROM PROTOCOL)?DATE OF THE MOST RECENT DOSE PRIOR TO THE ONSET OF EVENTS: 25/JAN | 0 | Q3W | |||||||||
| 126478073 | 12647807 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | (DOSAGE TAKEN FROM PROTOCOL)?DATE OF THE MOST RECENT DOSE PRIOR TO THE ONSET OF EVENTS: 25/JAN/2016 | 0 | 200 | MG/M**2 | Q3W | |||||||
| 126478073 | 12647807 | 6 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 126478073 | 12647807 | 7 | C | ADIRO | ASPIRIN | 1 | Unknown | 0 | |||||||||||
| 126478073 | 12647807 | 8 | C | ENALAPRIL | ENALAPRIL | 1 | Unknown | 0 | |||||||||||
| 126478073 | 12647807 | 9 | C | CEFIXIMA | CEFIXIME | 1 | Unknown | 0 | |||||||||||
| 126478073 | 12647807 | 10 | C | AUGMENTINE | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126478073 | 12647807 | 1 | Non-small cell lung cancer stage IV |
| 126478073 | 12647807 | 4 | Non-small cell lung cancer stage IV |
| 126478073 | 12647807 | 5 | Non-small cell lung cancer stage IV |
| 126478073 | 12647807 | 6 | Prophylaxis |
| 126478073 | 12647807 | 7 | Aortic aneurysm |
| 126478073 | 12647807 | 8 | Hypertension |
| 126478073 | 12647807 | 10 | Respiratory tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126478073 | 12647807 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126478073 | 12647807 | Pneumonitis | Pneumonitis |
| 126478073 | 12647807 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 126478073 | 12647807 | 1 | 20151117 | 0 | ||
| 126478073 | 12647807 | 2 | 20160606 | 0 | ||
| 126478073 | 12647807 | 4 | 20151117 | 20160125 | 0 | |
| 126478073 | 12647807 | 5 | 20151117 | 20160125 | 0 | |
| 126478073 | 12647807 | 7 | 2010 | 0 | ||
| 126478073 | 12647807 | 8 | 2014 | 0 | ||
| 126478073 | 12647807 | 9 | 20160425 | 20160501 | 0 | |
| 126478073 | 12647807 | 10 | 20160617 | 20160626 | 0 |