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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115951862 | 11595186 | 2 | F | 201302 | 20160921 | 20151006 | 20160927 | EXP | CA-ROCHE-1641527 | ROCHE | 36.13 | YR | M | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115951862 | 11595186 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 115951862 | 11595186 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW | U | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 115951862 | 11595186 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 115951862 | 11595186 | 10 | C | BRICANYL | TERBUTALINE SULFATE | 1 | Unknown | 0 | |||||||||||
| 115951862 | 11595186 | 11 | C | ALVESCO | CICLESONIDE | 1 | 0 | ||||||||||||
| 115951862 | 11595186 | 12 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 115951862 | 11595186 | 13 | C | NASONEX | MOMETASONE FUROATE | 1 | 0 | ||||||||||||
| 115951862 | 11595186 | 14 | C | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 115951862 | 11595186 | 15 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | ||||||||||||
| 115951862 | 11595186 | 16 | C | NASAL SALINE | SODIUM CHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115951862 | 11595186 | 1 | Asthma |
| 115951862 | 11595186 | 10 | Product used for unknown indication |
| 115951862 | 11595186 | 11 | Product used for unknown indication |
| 115951862 | 11595186 | 12 | Product used for unknown indication |
| 115951862 | 11595186 | 13 | Product used for unknown indication |
| 115951862 | 11595186 | 14 | Product used for unknown indication |
| 115951862 | 11595186 | 15 | Product used for unknown indication |
| 115951862 | 11595186 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115951862 | 11595186 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115951862 | 11595186 | Body temperature decreased | |
| 115951862 | 11595186 | Body temperature increased | |
| 115951862 | 11595186 | Cough | |
| 115951862 | 11595186 | Headache | |
| 115951862 | 11595186 | Lower respiratory tract infection | |
| 115951862 | 11595186 | Middle insomnia | |
| 115951862 | 11595186 | Nasal congestion | |
| 115951862 | 11595186 | Obstructive airways disorder | |
| 115951862 | 11595186 | Seasonal allergy | |
| 115951862 | 11595186 | Sinusitis | |
| 115951862 | 11595186 | Upper-airway cough syndrome | |
| 115951862 | 11595186 | Weight increased | |
| 115951862 | 11595186 | 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 |
|---|---|---|---|---|---|---|
| 115951862 | 11595186 | 1 | 20130123 | 0 | ||
| 115951862 | 11595186 | 2 | 20130204 | 0 | ||
| 115951862 | 11595186 | 3 | 20130318 | 0 | ||
| 115951862 | 11595186 | 4 | 20130905 | 0 | ||
| 115951862 | 11595186 | 5 | 20131017 | 0 | ||
| 115951862 | 11595186 | 6 | 20140120 | 0 | ||
| 115951862 | 11595186 | 7 | 20140303 | 0 | ||
| 115951862 | 11595186 | 8 | 20140428 | 0 | ||
| 115951862 | 11595186 | 9 | 20140512 | 0 |