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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537982 | 12453798 | 2 | F | 2007 | 20160624 | 20160609 | 20160701 | EXP | US-JAZZ-2016-US-010247 | JAZZ | 0.00 | F | Y | 0.00000 | 20160701 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537982 | 12453798 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124537982 | 12453798 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124537982 | 12453798 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 124537982 | 12453798 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124537982 | 12453798 | 5 | SS | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124537982 | 12453798 | 6 | SS | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124537982 | 12453798 | 7 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | N | 0 | CAPSULE | |||||||||
| 124537982 | 12453798 | 8 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124537982 | 12453798 | 9 | C | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124537982 | 12453798 | 10 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124537982 | 12453798 | 11 | C | DETROL LA | TOLTERODINE TARTRATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124537982 | 12453798 | 12 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124537982 | 12453798 | 13 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124537982 | 12453798 | 14 | C | Belladonna and phenobarbitone | 2 | UNK | U | 0 | TABLET | ||||||||||
| 124537982 | 12453798 | 15 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124537982 | 12453798 | 16 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124537982 | 12453798 | 17 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124537982 | 12453798 | 18 | C | Albuterol sulfate HFA | 2 | U | 0 | INHALER | |||||||||||
| 124537982 | 12453798 | 19 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | NASAL SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124537982 | 12453798 | 1 | Narcolepsy |
| 124537982 | 12453798 | 5 | Product used for unknown indication |
| 124537982 | 12453798 | 7 | Product used for unknown indication |
| 124537982 | 12453798 | 8 | Product used for unknown indication |
| 124537982 | 12453798 | 9 | Product used for unknown indication |
| 124537982 | 12453798 | 10 | Product used for unknown indication |
| 124537982 | 12453798 | 11 | Product used for unknown indication |
| 124537982 | 12453798 | 12 | Product used for unknown indication |
| 124537982 | 12453798 | 13 | Product used for unknown indication |
| 124537982 | 12453798 | 14 | Product used for unknown indication |
| 124537982 | 12453798 | 15 | Product used for unknown indication |
| 124537982 | 12453798 | 16 | Product used for unknown indication |
| 124537982 | 12453798 | 17 | Product used for unknown indication |
| 124537982 | 12453798 | 18 | Product used for unknown indication |
| 124537982 | 12453798 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124537982 | 12453798 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124537982 | 12453798 | Anxiety | |
| 124537982 | 12453798 | Apnoea | |
| 124537982 | 12453798 | Dizziness | |
| 124537982 | 12453798 | Gastric disorder | |
| 124537982 | 12453798 | Hypertension |
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 |
|---|---|---|---|---|---|---|
| 124537982 | 12453798 | 1 | 200602 | 200603 | 0 | |
| 124537982 | 12453798 | 2 | 200603 | 201412 | 0 | |
| 124537982 | 12453798 | 3 | 201412 | 201501 | 0 | |
| 124537982 | 12453798 | 4 | 201501 | 0 | ||
| 124537982 | 12453798 | 5 | 20130626 | 20151201 | 0 | |
| 124537982 | 12453798 | 6 | 20160518 | 0 | ||
| 124537982 | 12453798 | 7 | 20151112 | 201604 | 0 | |
| 124537982 | 12453798 | 8 | 20160425 | 0 | ||
| 124537982 | 12453798 | 9 | 201603 | 0 | ||
| 124537982 | 12453798 | 10 | 20151211 | 0 | ||
| 124537982 | 12453798 | 11 | 20151201 | 20151201 | 0 | |
| 124537982 | 12453798 | 12 | 20151201 | 0 | ||
| 124537982 | 12453798 | 13 | 20151201 | 20151201 | 0 | |
| 124537982 | 12453798 | 14 | 20151112 | 0 | ||
| 124537982 | 12453798 | 15 | 20151112 | 0 | ||
| 124537982 | 12453798 | 16 | 20151112 | 0 | ||
| 124537982 | 12453798 | 17 | 201603 | 0 |