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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107473699 | 10747369 | 9 | F | 201312 | 20160822 | 20150129 | 20160826 | EXP | US-ROCHE-1308797 | ROCHE | 36.20 | YR | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107473699 | 10747369 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 2 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 3 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 4 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | LAST DOSE PRIOR TO SAE WORSENING OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME:11/DEC/2013 | 5369 | 150 | MG | ||||||||
| 107473699 | 10747369 | 5 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 6 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 7 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 8 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 9 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 10 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 11 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | 5369 | 150 | MG | |||||||||
| 107473699 | 10747369 | 12 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 107473699 | 10747369 | 13 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | DAILY | 0 | ||||||||||
| 107473699 | 10747369 | 14 | C | ALVESCO | CICLESONIDE | 1 | Unknown | 0 | |||||||||||
| 107473699 | 10747369 | 15 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 107473699 | 10747369 | 16 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | 0 | ||||||||||||
| 107473699 | 10747369 | 17 | C | FISH OIL | FISH OIL | 1 | Oral | DAILY | 0 | ||||||||||
| 107473699 | 10747369 | 18 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | ||||||||||||
| 107473699 | 10747369 | 19 | C | LEVEMIR | INSULIN DETEMIR | 1 | Subcutaneous | 0 | |||||||||||
| 107473699 | 10747369 | 20 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 107473699 | 10747369 | 21 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 107473699 | 10747369 | 22 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107473699 | 10747369 | 1 | Asthma |
| 107473699 | 10747369 | 12 | Depression |
| 107473699 | 10747369 | 13 | Asthma |
| 107473699 | 10747369 | 14 | Asthma |
| 107473699 | 10747369 | 15 | Asthma |
| 107473699 | 10747369 | 16 | Headache |
| 107473699 | 10747369 | 17 | Pregnancy |
| 107473699 | 10747369 | 19 | Gestational diabetes |
| 107473699 | 10747369 | 20 | Gestational hypertension |
| 107473699 | 10747369 | 21 | Blood magnesium decreased |
| 107473699 | 10747369 | 22 | Pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107473699 | 10747369 | OT |
| 107473699 | 10747369 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107473699 | 10747369 | Anaemia | |
| 107473699 | 10747369 | Blood magnesium decreased | |
| 107473699 | 10747369 | Gestational diabetes | |
| 107473699 | 10747369 | Gestational hypertension | |
| 107473699 | 10747369 | Hypothyroidism | |
| 107473699 | 10747369 | Maternal exposure during pregnancy | |
| 107473699 | 10747369 | Postural orthostatic tachycardia syndrome | |
| 107473699 | 10747369 | Premature labour | |
| 107473699 | 10747369 | Rash | |
| 107473699 | 10747369 | Umbilical cord around neck |
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 |
|---|---|---|---|---|---|---|
| 107473699 | 10747369 | 1 | 20111223 | 0 | ||
| 107473699 | 10747369 | 2 | 20130924 | 0 | ||
| 107473699 | 10747369 | 3 | 20131024 | 0 | ||
| 107473699 | 10747369 | 4 | 20131121 | 0 | ||
| 107473699 | 10747369 | 5 | 20131219 | 0 | ||
| 107473699 | 10747369 | 6 | 20140311 | 0 | ||
| 107473699 | 10747369 | 7 | 20140428 | 0 | ||
| 107473699 | 10747369 | 8 | 20140530 | 0 | ||
| 107473699 | 10747369 | 9 | 20140731 | 0 | ||
| 107473699 | 10747369 | 10 | 20140821 | 0 | ||
| 107473699 | 10747369 | 11 | 20140924 | 20140924 | 0 | |
| 107473699 | 10747369 | 13 | 2014 | 0 | ||
| 107473699 | 10747369 | 15 | 2014 | 0 | ||
| 107473699 | 10747369 | 19 | 201312 | 2014 | 0 | |
| 107473699 | 10747369 | 20 | 20140620 | 20140623 | 0 | |
| 107473699 | 10747369 | 21 | 20140620 | 20140623 | 0 | |
| 107473699 | 10747369 | 22 | 2014 | 0 |