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This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodinated contrast agents | Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodinated contrast agents | Drug | Use of iodine contrast agents and doses following the decision of the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice | Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk. | In the 365 days post exposure to an iodinated contrast agent |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent | |
| Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort |
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Inclusion Criteria:
Exclusion Criteria:
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Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | Oakland | California | 94612 | United States |
There were 2320 children identified in Kaiser Permanente Northern California who met our study population criteria: patients who had a procedure that used iodinated contrast agent and were under the age of 4, during the years 2008 to June of 2016.
This study was a retrospective cohort study, using the data from the years 2008 to June of 2016 in the database of Kaiser Permanente Northern California.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodine Contrast Agent | Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodine Contrast Agent | Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice | Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk. | Posted | Mean | 95% Confidence Interval | events per 1,000 person years | In the 365 days post exposure to an iodinated contrast agent |
|
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Incidence of hypothyroidism was assessed up to one year after iodine contrast exposure
This study is a retrospective study using data from the database in United States. The safety outcome focused on the incidence of hypothyroidism for up to one year after iodine contrast exposure. Please refer to the result of primary outcome measure. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed during this retrospective observation study. Only retrospective safety outcome data were assessed, which are on the outcome measures module.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodine Contrast Agent | Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2016 | May 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Time From First Iodinated Contrast to First Hypothyroidism Event | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Classification of Hypothyroidism by Etiology | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Participants |
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| Secondary | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| Secondary | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| Secondary | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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|
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| Secondary | Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | Posted | Count of Units | Iodine contrast exposure | Up to 365 days after a diagnostic scan with iodinated contrast agent | Iodine contrast exposure | Iodine contrast exposure |
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| Secondary | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| Secondary | Time From First Iodinated Contrast to First Hypothyroidism Event | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| Secondary | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| Secondary | Classification of Hypothyroidism by Etiology | Posted | Count of Participants | Participants | Up to 365 days after a diagnostic scan with iodinated contrast agent |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| 3 to 6 months |
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| 6 months to 1 year |
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| 1 to 4 years |
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| 2010 |
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| 2011 |
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| 2012 |
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| 2013 |
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| 2014 |
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| 2015 |
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| through August 2016 |
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| Hispanic |
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| Asian/Pacific islander |
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| Other or missing |
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| 60+ days |
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| Treatment or diagnosis with no TSH test |
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