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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127586351 | 12758635 | 1 | I | 201608 | 20160908 | 20160919 | 20160919 | EXP | US-RECORDATI RARE DISEASES-US-R13005-16-00234 | RECORDATI | 65.50 | YR | F | Y | 52.66000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127586351 | 12758635 | 1 | PS | TRANXENE T-TAB | CLORAZEPATE DIPOTASSIUM | 1 | Unknown | 17105 | UNKNOWN | ||||||||||
| 127586351 | 12758635 | 2 | SS | TRANXENE T-TAB | CLORAZEPATE DIPOTASSIUM | 1 | Oral | 17105 | 15 | MG | TABLETS | TID | |||||||
| 127586351 | 12758635 | 3 | SS | TRANXENE T-TAB | CLORAZEPATE DIPOTASSIUM | 1 | Oral | 17105 | 7.5 | MG | TABLETS | TID | |||||||
| 127586351 | 12758635 | 4 | SS | XANAX | ALPRAZOLAM | 1 | Unknown | 0 | |||||||||||
| 127586351 | 12758635 | 5 | SS | NOVOCAINE | PROCAINE | 1 | Unknown | 0 | |||||||||||
| 127586351 | 12758635 | 6 | SS | FLU SHOT | INFLUENZA VIRUS VACCINE | 1 | Unknown | 0 | |||||||||||
| 127586351 | 12758635 | 7 | C | PREMARIN | ESTROGENS, CONJUGATED | 1 | Unknown | 0 | .625 | MG | QD | ||||||||
| 127586351 | 12758635 | 8 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | 200 | MG | QD | ||||||||
| 127586351 | 12758635 | 9 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | 0 | 250 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127586351 | 12758635 | 1 | Panic attack |
| 127586351 | 12758635 | 4 | Product used for unknown indication |
| 127586351 | 12758635 | 5 | Product used for unknown indication |
| 127586351 | 12758635 | 6 | Product used for unknown indication |
| 127586351 | 12758635 | 7 | Product used for unknown indication |
| 127586351 | 12758635 | 8 | Pain in extremity |
| 127586351 | 12758635 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127586351 | 12758635 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127586351 | 12758635 | Anxiety | |
| 127586351 | 12758635 | Asthenia | |
| 127586351 | 12758635 | Chest discomfort | |
| 127586351 | 12758635 | Fatigue | |
| 127586351 | 12758635 | Feeling abnormal | |
| 127586351 | 12758635 | Impaired driving ability | |
| 127586351 | 12758635 | Impaired work ability | |
| 127586351 | 12758635 | Malaise | |
| 127586351 | 12758635 | Off label use | |
| 127586351 | 12758635 | Palpitations | |
| 127586351 | 12758635 | Soliloquy | |
| 127586351 | 12758635 | Withdrawal 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 |
|---|---|---|---|---|---|---|
| 127586351 | 12758635 | 2 | 20160808 | 0 | ||
| 127586351 | 12758635 | 3 | 20160908 | 0 |