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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123399864 | 12339986 | 4 | F | 20160104 | 20160913 | 20160506 | 20160921 | EXP | CA-ROCHE-1753265 | ROCHE | 68.78 | YR | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123399864 | 12339986 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, BIW (EVERY 2 WEEKS) | U | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 123399864 | 12339986 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 123399864 | 12339986 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 123399864 | 12339986 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | REDUCED BY 10 MG EACH WEEK | U | 0 | 40 | MG | QD | ||||||
| 123399864 | 12339986 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | REDUCED BY 10 MG EACH WEEK | U | 0 | 10 | MG | QD | ||||||
| 123399864 | 12339986 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 123399864 | 12339986 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | INHALATION VAPOUR |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123399864 | 12339986 | 1 | Asthma |
| 123399864 | 12339986 | 3 | Lower respiratory tract infection |
| 123399864 | 12339986 | 4 | Asthma |
| 123399864 | 12339986 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123399864 | 12339986 | OT |
| 123399864 | 12339986 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123399864 | 12339986 | Asthma | |
| 123399864 | 12339986 | Dyspnoea | |
| 123399864 | 12339986 | Forced expiratory volume decreased | |
| 123399864 | 12339986 | Forced vital capacity decreased | |
| 123399864 | 12339986 | Lower respiratory tract infection | |
| 123399864 | 12339986 | Lung infection | |
| 123399864 | 12339986 | Nasopharyngitis | |
| 123399864 | 12339986 | Respiratory tract congestion | |
| 123399864 | 12339986 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 123399864 | 12339986 | 1 | 20151125 | 0 | ||
| 123399864 | 12339986 | 2 | 20160629 | 0 | ||
| 123399864 | 12339986 | 4 | 20160106 | 0 | ||
| 123399864 | 12339986 | 6 | 201606 | 0 |