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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127810491 | 12781049 | 1 | I | 2015 | 20160913 | 20160926 | 20160926 | EXP | US-JUBILANT CADISTA PHARMACEUTICALS-2016JUB00334 | JUBILANT | 65.86 | YR | F | Y | 58.50000 | KG | 20160926 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127810491 | 12781049 | 1 | PS | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, 1X/DAY | Y | 40362 | 20 | MG | TABLET | QD | |||||
| 127810491 | 12781049 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | 60 MG, 1X/DAY | Y | 40362 | 60 | MG | TABLET | QD | ||||||
| 127810491 | 12781049 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | Y | 40362 | TABLET | |||||||||
| 127810491 | 12781049 | 4 | SS | ALBUTEROL, RESCUE INHALER | ALBUTEROL | 1 | 6 TIMES DAILY, AS NEEDED | Y | 0 | INHALATION GAS | |||||||||
| 127810491 | 12781049 | 5 | SS | ALBUTEROL, RESCUE INHALER | ALBUTEROL | 1 | 3 TO 4, AS NEEDED | Y | 0 | INHALATION GAS | |||||||||
| 127810491 | 12781049 | 6 | SS | ALBUTEROL. | ALBUTEROL | 1 | UNK UNK, AS NEEDED | Y | 0 | ||||||||||
| 127810491 | 12781049 | 7 | SS | ALBUTEROL IPRATROPIUM | ALBUTEROLIPRATROPIUM | 1 | UNK | Y | 0 | ||||||||||
| 127810491 | 12781049 | 8 | SS | CROMOLYN | CROMOLYN | 1 | UNK | Y | 0 | ||||||||||
| 127810491 | 12781049 | 9 | SS | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | Y | U | 0 | |||||||||
| 127810491 | 12781049 | 10 | SS | UNSPECIFIED ANTIBIOTIC | UNSPECIFIED INGREDIENT | 1 | U | U | 0 | ||||||||||
| 127810491 | 12781049 | 11 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK, 4X/DAY | 0 | QID | ||||||||||
| 127810491 | 12781049 | 12 | C | CHLORTHALIDONE. | CHLORTHALIDONE | 1 | 25 MG, UNK | 0 | 25 | MG | |||||||||
| 127810491 | 12781049 | 13 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 127810491 | 12781049 | 14 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | 45 MG, UNK | 0 | 45 | MG | |||||||||
| 127810491 | 12781049 | 15 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 1 MG, UNK | 0 | 1 | MG | |||||||||
| 127810491 | 12781049 | 16 | C | ALEVE | NAPROXEN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127810491 | 12781049 | 1 | Asthma |
| 127810491 | 12781049 | 4 | Asthma |
| 127810491 | 12781049 | 6 | Asthma |
| 127810491 | 12781049 | 7 | Asthma |
| 127810491 | 12781049 | 8 | Asthma |
| 127810491 | 12781049 | 11 | Asthma |
| 127810491 | 12781049 | 12 | Blood pressure measurement |
| 127810491 | 12781049 | 13 | Asthma |
| 127810491 | 12781049 | 14 | Depression |
| 127810491 | 12781049 | 15 | Sleep disorder |
| 127810491 | 12781049 | 16 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127810491 | 12781049 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127810491 | 12781049 | Bronchitis | |
| 127810491 | 12781049 | Drug ineffective | |
| 127810491 | 12781049 | Dyspnoea | |
| 127810491 | 12781049 | Immune system disorder | |
| 127810491 | 12781049 | Insomnia | |
| 127810491 | 12781049 | Memory impairment | |
| 127810491 | 12781049 | Sleep apnoea syndrome |
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 |
|---|---|---|---|---|---|---|
| 127810491 | 12781049 | 1 | 201506 | 201508 | 0 | |
| 127810491 | 12781049 | 4 | 201608 | 0 | ||
| 127810491 | 12781049 | 5 | 201608 | 0 | ||
| 127810491 | 12781049 | 6 | 20150619 | 201608 | 0 | |
| 127810491 | 12781049 | 7 | 20150626 | 201608 | 0 | |
| 127810491 | 12781049 | 8 | 201508 | 201608 | 0 | |
| 127810491 | 12781049 | 11 | 2013 | 0 | ||
| 127810491 | 12781049 | 12 | 2014 | 0 | ||
| 127810491 | 12781049 | 15 | 2011 | 0 |