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To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodinated contrast agents | children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iodinated contrast agents | Drug | Intravascular application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting | Up to one year after iodinated contrast material (ICM) exposure (828 person years) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to one year after ICM exposure (828 person years) | |
| Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | At first examination |
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Inclusion Criteria:
- All children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g.
contrast enhanced CT, cardioangiography)
Exclusion Criteria:
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Members of Maccabi Health Services database (Israel)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Israel |
Between 1.1.1998 and 31.12.2015, 877 participants were identified. After applying exclusion criteria, 34 participants were excluded from the initial cohort and the final cohort consisted of 843 participants.
This study was a retrospective cohort study, using the data from the years 1998 until 2015 in the database of Maccabi Health Services (Israel).
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodine Contrast Agent | The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: thyroid-stimulating hormone (TSH) levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Final Cohort
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodine Contrast Agent | The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting | Final Cohort | Posted | Count of Participants | Participants | Up to one year after iodinated contrast material (ICM) exposure (828 person years) |
|
Up to one year after contrast exposure.
This study is a retrospective study using data from the database in Israel. The safety outcome focused on the incidence of hypothyroidism for up to one year after iodine contrast exposure, detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy. Please refer to the result of primary outcome measure.
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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 | The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy. |
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This study is a retrospective database analysis study. 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 for safety evaluation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | +49 30 300139003 | clinical-trials-contact@bayer.com |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort | Within a range of ±360 days of the first examination |
| Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Prior to first examination |
| Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) |
| Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) |
| Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) |
| Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) |
| Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism | Up to one year after ICM exposure (828 person years) |
| The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category | Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below. | Up to one year after ICM exposure (828 person years) |
| The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category | Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below. | Up to one year after ICM exposure (828 person years) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Comorbidity | Number | Participants |
|
| Sum of Examinations | Count of Participants | Participants |
|
| Type of 1st examination | Count of Participants | Participants |
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| Type of >=2nd examination | Participants in final cohort who underwent the 2nd examination | Count of Participants | Participants |
|
| Time between examinations | Mean | Standard Deviation | Days |
|
| Dispenses of hypothyroidism inducing drugs | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Final Cohort | Posted | Count of Participants | Participants | Up to one year after ICM exposure (828 person years) |
|
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| Secondary | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | Final Cohort | Posted | Mean | Standard Deviation | Years | At first examination |
|
|
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| Secondary | Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort | Final Cohort | Posted | Mean | Standard Deviation | Kilograms | Within a range of ±360 days of the first examination |
|
|
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| Secondary | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Final Cohort | Posted | Count of Participants | Participants | Prior to first examination |
|
|
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| Secondary | Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Final Cohort | Posted | Count of Participants | Participants | Up to one year after ICM exposure (828 person years) |
|
|
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| Secondary | Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Final Cohort | Posted | Count of Participants | Participants | Up to one year after ICM exposure (828 person years) |
|
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| Secondary | Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Final Cohort | Posted | Count of Participants | Participants | Up to one year after ICM exposure (828 person years) |
|
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| Secondary | Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Final Cohort | Posted | Mean | Standard Deviation | Days | Up to one year after ICM exposure (828 person years) |
|
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| Secondary | Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism | Final Cohort | Posted | Mean | Standard Deviation | Days | Up to one year after ICM exposure (828 person years) |
|
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| Secondary | The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category | Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below. | Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified. | Posted | Number | Months | Up to one year after ICM exposure (828 person years) |
|
|
|
| Secondary | The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category | Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below. | Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified. | Posted | Number | Months | Up to one year after ICM exposure (828 person years) |
|
|
|
| Secondary | The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category | Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below. | Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified. | Posted | Number | Days | Up to one year after ICM exposure (828 person years) |
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| 0 |
| 0 |
| 0 |
| 0 |
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| Cancer |
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| Overweight |
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| Second and third |
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| Third and fourth |
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| Title | Measurements |
|---|---|
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| Case number 10 |
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