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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109263554 | 10926355 | 4 | F | 20140209 | 20160914 | 20150318 | 20160920 | EXP | PHEH2014US003262 | NOVARTIS | 11.30 | YR | M | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109263554 | 10926355 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 910 | MG | Y | U | 22334 | 5 | MG | TABLET | QD | ||
| 109263554 | 10926355 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 910 | MG | Y | U | 22334 | 5 | MG | TABLET | QD | ||
| 109263554 | 10926355 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 910 | MG | Y | U | 22334 | 5 | MG | TABLET | QD | ||
| 109263554 | 10926355 | 4 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 910 | MG | Y | U | 22334 | 5 | MG | TABLET | QD | ||
| 109263554 | 10926355 | 5 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | UNK | 910 | MG | Y | U | 22334 | TABLET | |||||
| 109263554 | 10926355 | 6 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, UNK | 910 | MG | Y | U | 22334 | 7.5 | MG | TABLET | |||
| 109263554 | 10926355 | 7 | SS | SUDAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 1 | Unknown | Y | 0 | ||||||||||
| 109263554 | 10926355 | 8 | C | SEPTRA | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | 0 | ||||||||||
| 109263554 | 10926355 | 9 | C | DIASTAT | DIAZEPAM | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 109263554 | 10926355 | 10 | C | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | Unknown | UNK UKN, PRN | U | 0 | |||||||||
| 109263554 | 10926355 | 11 | C | MELATONIN | MELATONIN | 1 | Oral | 3 MG, QD | U | 0 | 3 | MG | TABLET | QD | |||||
| 109263554 | 10926355 | 12 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 750 MG, BID | 0 | 750 | MG | TABLET | BID | ||||||
| 109263554 | 10926355 | 13 | C | LORATADINE. | LORATADINE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 109263554 | 10926355 | 14 | C | TENEX | GUANFACINE HYDROCHLORIDE | 1 | Oral | 1.5 MG, BID | 0 | 1.5 | MG | TABLET | BID | ||||||
| 109263554 | 10926355 | 15 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 DF, BID | U | 0 | 2 | DF | INHALER | BID | |||||
| 109263554 | 10926355 | 16 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 109263554 | 10926355 | 17 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 375 MG, BID | U | 0 | 375 | MG | TABLET | BID | |||||
| 109263554 | 10926355 | 18 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109263554 | 10926355 | 1 | Ganglioglioma |
| 109263554 | 10926355 | 2 | Astrocytoma, low grade |
| 109263554 | 10926355 | 7 | Product used for unknown indication |
| 109263554 | 10926355 | 8 | Product used for unknown indication |
| 109263554 | 10926355 | 9 | Product used for unknown indication |
| 109263554 | 10926355 | 10 | Product used for unknown indication |
| 109263554 | 10926355 | 11 | Product used for unknown indication |
| 109263554 | 10926355 | 12 | Blood triglycerides increased |
| 109263554 | 10926355 | 13 | Product used for unknown indication |
| 109263554 | 10926355 | 14 | Product used for unknown indication |
| 109263554 | 10926355 | 15 | Product used for unknown indication |
| 109263554 | 10926355 | 16 | Product used for unknown indication |
| 109263554 | 10926355 | 17 | Product used for unknown indication |
| 109263554 | 10926355 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109263554 | 10926355 | HO |
| 109263554 | 10926355 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109263554 | 10926355 | Arthralgia | |
| 109263554 | 10926355 | Contusion | |
| 109263554 | 10926355 | Conversion disorder | |
| 109263554 | 10926355 | Cough | |
| 109263554 | 10926355 | Ear infection | |
| 109263554 | 10926355 | Ear pain | |
| 109263554 | 10926355 | Foot fracture | |
| 109263554 | 10926355 | Fracture | |
| 109263554 | 10926355 | Inappropriate affect | |
| 109263554 | 10926355 | Joint injury | |
| 109263554 | 10926355 | Joint swelling | |
| 109263554 | 10926355 | Lacrimation increased | |
| 109263554 | 10926355 | Lip haemorrhage | |
| 109263554 | 10926355 | Lip swelling | |
| 109263554 | 10926355 | Malaise | |
| 109263554 | 10926355 | Pyrexia | |
| 109263554 | 10926355 | Retching | |
| 109263554 | 10926355 | Rhinorrhoea | |
| 109263554 | 10926355 | Seizure | |
| 109263554 | 10926355 | Sinusitis | |
| 109263554 | 10926355 | Stress fracture | |
| 109263554 | 10926355 | Swelling | |
| 109263554 | 10926355 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 109263554 | 10926355 | 1 | 20140109 | 20140210 | 0 | |
| 109263554 | 10926355 | 2 | 20140214 | 20140525 | 0 | |
| 109263554 | 10926355 | 3 | 20140530 | 0 | ||
| 109263554 | 10926355 | 4 | 20141218 | 20150203 | 0 | |
| 109263554 | 10926355 | 5 | 20150225 | 20160702 | 0 | |
| 109263554 | 10926355 | 6 | 20160728 | 0 |