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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120997295 | 12099729 | 5 | F | 20140826 | 20160623 | 20160222 | 20160701 | EXP | PHHY2014US139883 | SANDOZ | 56.96 | YR | F | Y | 101.30000 | KG | 20160701 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120997295 | 12099729 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EVERY 2 IN 1 MONTH, START LATE 2005/EARLY 2006 | U | 0 | 150 | MG | |||||||
| 120997295 | 12099729 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, 1 IN 1 WEEK, START LATE 2005/EARLY 2006 | U | 0 | 150 | MG | /wk | ||||||
| 120997295 | 12099729 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 120997295 | 12099729 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW (EVERY 2 WEEKS) | U | 0 | 300 | MG | QOW | ||||||
| 120997295 | 12099729 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | 0 | 375 | MG | QOW | ||||||
| 120997295 | 12099729 | 6 | PS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | REPLACED ^LEVOCITRINE^ | 81127 | ||||||||||
| 120997295 | 12099729 | 7 | SS | ZAFIRLUKAST. | ZAFIRLUKAST | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 120997295 | 12099729 | 8 | C | ACCOLATE | ZAFIRLUKAST | 1 | Unknown | FOR 8-10 YEARS | Y | 0 | |||||||||
| 120997295 | 12099729 | 9 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Unknown | 10 MG, QD (FOR 4 YEARS) | Y | 0 | 10 | MG | QD | ||||||
| 120997295 | 12099729 | 10 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 250 MG, BID (1 PUFF MORNING) | U | 0 | 250 | MG | BID | ||||||
| 120997295 | 12099729 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 90 MG, QD (2 PUFFS MID DAY) | U | 0 | 90 | MG | QD | ||||||
| 120997295 | 12099729 | 12 | C | ALVESCO | CICLESONIDE | 1 | Respiratory (inhalation) | 1PUFF (FOR 5 YEARS), | Y | 0 | 1 | DF | |||||||
| 120997295 | 12099729 | 13 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | QD (2 PUFFS),MID DAY | U | 0 | QD | ||||||||
| 120997295 | 12099729 | 14 | C | DIOVAN | VALSARTAN | 1 | Unknown | 160/12.5 IN THE MORNING, QD | U | 0 | INHALER | QD | |||||||
| 120997295 | 12099729 | 15 | C | DILTIAZEM. | DILTIAZEM | 1 | Unknown | 240 MG, QD (IN THE EVENING) | U | 0 | 240 | MG | QD | ||||||
| 120997295 | 12099729 | 16 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 4 MG, UNK | Y | 0 | 4 | MG | |||||||
| 120997295 | 12099729 | 17 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 1 MG, BID, FOR A YEAR, DISCONTINUED | Y | 0 | 1 | MG | BID | ||||||
| 120997295 | 12099729 | 18 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | SPORADICALLY; DISCONTINUED | Y | 0 | |||||||||
| 120997295 | 12099729 | 19 | C | NABUMETONE. | NABUMETONE | 1 | Unknown | 500 MG, BID | U | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120997295 | 12099729 | 1 | Asthma |
| 120997295 | 12099729 | 6 | Asthma |
| 120997295 | 12099729 | 7 | Asthma |
| 120997295 | 12099729 | 8 | Asthma |
| 120997295 | 12099729 | 9 | Asthma |
| 120997295 | 12099729 | 10 | Asthma |
| 120997295 | 12099729 | 11 | Asthma |
| 120997295 | 12099729 | 12 | Asthma |
| 120997295 | 12099729 | 13 | Asthma |
| 120997295 | 12099729 | 14 | Hypertension |
| 120997295 | 12099729 | 15 | Hypertension |
| 120997295 | 12099729 | 16 | Asthma |
| 120997295 | 12099729 | 19 | Inflammation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120997295 | 12099729 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120997295 | 12099729 | Arthritis | |
| 120997295 | 12099729 | Asthma | |
| 120997295 | 12099729 | Disability | |
| 120997295 | 12099729 | Ear pruritus | |
| 120997295 | 12099729 | Eye pruritus | |
| 120997295 | 12099729 | General physical health deterioration | |
| 120997295 | 12099729 | Hypersensitivity | |
| 120997295 | 12099729 | Malaise | |
| 120997295 | 12099729 | Nasopharyngitis | |
| 120997295 | 12099729 | Rhinorrhoea | |
| 120997295 | 12099729 | Rotator cuff syndrome | |
| 120997295 | 12099729 | Scoliosis | |
| 120997295 | 12099729 | Stress | |
| 120997295 | 12099729 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 120997295 | 12099729 | 1 | 20140829 | 0 | ||
| 120997295 | 12099729 | 3 | 20141217 | 0 | ||
| 120997295 | 12099729 | 6 | 201407 | 0 | ||
| 120997295 | 12099729 | 7 | 201407 | 0 | ||
| 120997295 | 12099729 | 8 | 201407 | 0 | ||
| 120997295 | 12099729 | 9 | 2001 | 0 | ||
| 120997295 | 12099729 | 12 | 201403 | 0 | ||
| 120997295 | 12099729 | 13 | 201403 | 0 | ||
| 120997295 | 12099729 | 16 | 201303 | 0 |