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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121874296 | 12187429 | 6 | F | 20130802 | 20160809 | 20160317 | 20160812 | EXP | PHHY2013CA085616 | NOVARTIS | 53.45 | YR | F | Y | 0.00000 | 20160812 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121874296 | 12187429 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 2 WEEKS | U | 0 | 300 | MG | VIAL | QOW | |||||
| 121874296 | 12187429 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 121874296 | 12187429 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 121874296 | 12187429 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 121874296 | 12187429 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 121874296 | 12187429 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062 | 0 | VIAL | |||||||
| 121874296 | 12187429 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 0 | VIAL | |||||||
| 121874296 | 12187429 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B | 0 | VIAL | |||||||
| 121874296 | 12187429 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | VIAL | ||||||||
| 121874296 | 12187429 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0003C | 0 | VIAL | |||||||
| 121874296 | 12187429 | 11 | PS | SEEBRI BREEZHALER | GLYCOPYRROLATE | 1 | Respiratory (inhalation) | U | 207923 | ||||||||||
| 121874296 | 12187429 | 12 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | U | 0 | ||||||||||
| 121874296 | 12187429 | 13 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121874296 | 12187429 | 1 | Asthma |
| 121874296 | 12187429 | 11 | Product used for unknown indication |
| 121874296 | 12187429 | 12 | Product used for unknown indication |
| 121874296 | 12187429 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121874296 | 12187429 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121874296 | 12187429 | Arthralgia | |
| 121874296 | 12187429 | Blood pressure increased | |
| 121874296 | 12187429 | Body temperature decreased | |
| 121874296 | 12187429 | Breath sounds abnormal | |
| 121874296 | 12187429 | Carpal tunnel syndrome | |
| 121874296 | 12187429 | Chest pain | |
| 121874296 | 12187429 | Cough | |
| 121874296 | 12187429 | Discomfort | |
| 121874296 | 12187429 | Dizziness | |
| 121874296 | 12187429 | Dysphonia | |
| 121874296 | 12187429 | Dyspnoea | |
| 121874296 | 12187429 | Erythema | |
| 121874296 | 12187429 | Feeling hot | |
| 121874296 | 12187429 | Headache | |
| 121874296 | 12187429 | Hypoaesthesia | |
| 121874296 | 12187429 | Jaw disorder | |
| 121874296 | 12187429 | Lower respiratory tract infection | |
| 121874296 | 12187429 | Malaise | |
| 121874296 | 12187429 | Rales | |
| 121874296 | 12187429 | Rash | |
| 121874296 | 12187429 | Sinusitis | |
| 121874296 | 12187429 | Skin reaction | |
| 121874296 | 12187429 | Sleep disorder | |
| 121874296 | 12187429 | Stress | |
| 121874296 | 12187429 | 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 |
|---|---|---|---|---|---|---|
| 121874296 | 12187429 | 1 | 20130510 | 0 | ||
| 121874296 | 12187429 | 2 | 20131030 | 0 | ||
| 121874296 | 12187429 | 3 | 20131127 | 0 | ||
| 121874296 | 12187429 | 4 | 20140206 | 0 | ||
| 121874296 | 12187429 | 5 | 20140807 | 0 | ||
| 121874296 | 12187429 | 6 | 20160302 | 0 | ||
| 121874296 | 12187429 | 7 | 20160331 | 0 | ||
| 121874296 | 12187429 | 8 | 20160512 | 0 | ||
| 121874296 | 12187429 | 9 | 20160531 | 0 | ||
| 121874296 | 12187429 | 10 | 20160721 | 0 |