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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104360724 | 10436072 | 4 | F | 20160627 | 20140908 | 20160703 | EXP | CA-ROCHE-1459265 | ROCHE | 0.00 | F | Y | 0.00000 | 20160704 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104360724 | 10436072 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | 103976 | 375 | MG | QOW | ||||||
| 104360724 | 10436072 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 104360724 | 10436072 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 25 MG (INCREASED IN DOSE FROM 5 MG) | 0 | 5 | MG | QD | |||||||
| 104360724 | 10436072 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 15 MG, QD | 0 | 20 | MG | QD | |||||||
| 104360724 | 10436072 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 15 | MG | QD | ||||||||
| 104360724 | 10436072 | 6 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 2 DF (2 PUFFS), QD | U | 0 | 2 | DF | QD | ||||||
| 104360724 | 10436072 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | 2-3 TIMES A WEEK OR DAILYUNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104360724 | 10436072 | 1 | Asthma |
| 104360724 | 10436072 | 2 | Asthma |
| 104360724 | 10436072 | 3 | Cystic fibrosis |
| 104360724 | 10436072 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104360724 | 10436072 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104360724 | 10436072 | Asthma | |
| 104360724 | 10436072 | Chest discomfort | |
| 104360724 | 10436072 | Condition aggravated | |
| 104360724 | 10436072 | Cough | |
| 104360724 | 10436072 | Crepitations | |
| 104360724 | 10436072 | Cystic fibrosis | |
| 104360724 | 10436072 | Dyspnoea | |
| 104360724 | 10436072 | Heart rate increased | |
| 104360724 | 10436072 | Middle insomnia | |
| 104360724 | 10436072 | Oxygen saturation decreased | |
| 104360724 | 10436072 | Respiratory disorder |
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 |
|---|---|---|---|---|---|---|
| 104360724 | 10436072 | 1 | 20131028 | 0 |