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The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
This study is a prospective, single arm, multi-center, in-clinic study.. There will be two consecutive phases of the study:
A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational centers
Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™ and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement is for subjects 2-6 years of age and cannot tolerate YSI.
Study has a run-in period and a study period with a total of 10 visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlite sensors | Experimental | Each subject will first wear enlite sensors and will come for clinic visit for YSI (Yellow Spring Instruments). Then each subject will wear enlite 3 sensors and will come for clinic visit for YSI (Yellow Spring Instruments) or SMBG (Self-Monitoring of Blood Glucose) testing. SMBG testings are for subjects 2-6 years of age and cannot tolerate YSI. In addition. In addition, subjects aged 2-6 years old will not participate in Enlite phase. They only participate in Enlite 3 phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlite sensors | Device | Subject wears enlite sensor first and followed by enlite 3 sensor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump | Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | 6 days |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Brazg, MD | Rainier Clinical Research Center | Principal Investigator |
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Jeanie Tryggestad, MD | OUHSC Department of Pediatrics | Principal Investigator |
| Linda DiMeglio, MD | Indiana University, Riley Hospital for Children | Principal Investigator |
| Larry Fox, MD | Nemours Children's Clinic | Principal Investigator |
| Jennifer Sherr, MD | Yale University, Yale Diabetes Research Program | Principal Investigator |
| Robert Slover, MD | Barbara Davis Center | Principal Investigator |
| Eva Tsalikian, MD | University of Iowa Children Hospital | Principal Investigator |
| Bruce Bode, MD | Atlanta Diabetes Associates | Principal Investigator |
| Kevin Kaiserman, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| SoCal Diabetes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30063162 | Derived | Slover RH, Tryggestad JB, DiMeglio LA, Fox LA, Bode BW, Bailey TS, Brazg R, Christiansen MP, Sherr JL, Tsalikian E, Kaiserman KB, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2018 Sep;20(9):576-584. doi: 10.1089/dia.2018.0109. Epub 2018 Jul 31. |
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Two phase study: Enlite and Enlite 3. Some participated only Enlite phase and some only participated in Enlite 3 phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-18 Years Old Wearing Sensors | 2-18 years old wearing Enlite and/or Enlite3 sensors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enlite 1 Period |
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| Enlite 3 Period |
|
a total of 186 subjects participated the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-18 Year Olds Wearing Enlite Sensor | 2-18 years old wearing Enlite and/or Enlite3 sensors. |
| 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 | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump | Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | All subjects wearing Enlite sensor with lower serial number of 530G pump. A total of 30 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 6 days |
|
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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 | 2-18 Year Olds Wearing Enlite Sensors | 2-18 year olds wearing Enlite Sensors | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suiying Huang, Statistician | Medtronic Minimed | 818-576-3319 | suiying.huang@medtronic.com |
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| 7 days |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump | Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | 6 Days |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | 6 Days |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | 6 Days |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | 7 Days |
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | 7 Days |
| SoCal Diabetes |
| Principal Investigator |
| Mark Christiansen, MD | Diablo Clinical Research | Principal Investigator |
| Torrance |
| California |
| 90505 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| Yale University, Yale Diabetes Research Program | New Haven | Connecticut | 06511 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| "Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Indiana University, Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Children Hospital | Iowa City | Iowa | 52242 | United States |
| OUHSC Department of Pediatrics | Oklahoma City | Oklahoma | 73104 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | a total of 25 subjects do not have device data | Posted | Mean | Standard Deviation | percentage of difference | 7 days |
|
|
|
| Secondary | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | A total of 41 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 7 days |
|
|
|
| Secondary | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump | Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | All subjects wearing Enlite sensors with high serial number 530G pump. A total of 35 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 6 Days |
|
|
|
| Secondary | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | A total of 32 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 6 Days |
|
|
|
| Secondary | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST | Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose. | A total of 34 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 6 Days |
|
|
|
| Secondary | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST | Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | A total of 34 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 7 Days |
|
|
|
| Secondary | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST | Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose. | A total of 41 subjects did not have device data. | Posted | Mean | Standard Deviation | percentage of difference | 7 Days |
|
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| 161 |
| 2 |
| 161 |
| 25 |
| 161 |
| EG001 | 2-18 Year Olds Wearing Enlite3 Sensors | 2-18 year olds wearing Enlite3 Sensors | 0 | 158 | 1 | 158 | 23 | 158 |
| Pilonidal Abscess | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| Influenzavirus B | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Broken right thumb | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Flu symptoms | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| Food poisoning. | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Hypersensitivity reaction | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Hypoglycemic Seizure | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Insertion site pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Laceration above right knee cap - requiring 9 sutures | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
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| Left Broken Great Toe | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Puncture Wound | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Sinus Infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Stomach Virus | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Toe Injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Upper Resiratory Infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| common cold | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| jaw pain due to wisdom teeth removal | Surgical and medical procedures | MedDRA (15.0) | Non-systematic Assessment |
|
| lowgrade fever, maximum 100.8 degrees | General disorders | MedDRA (15.0) | Non-systematic Assessment |
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| severe hyperglycemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
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| skin irritation | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| vasovagal response | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Abrasion on right arm and right leg | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Cold sore | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Food Allergy: Shellfish Positive FPIES (Food PRotein Induced Enterocolitis Syndrome) | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Staff Infection left upper arm | Investigations | MedDRA (15.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| contact dermatitis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
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| fatigue | General disorders | MedDRA (15.0) | Non-systematic Assessment |
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| hand, foot, mouth disease 0 | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
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| sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| sprain of left wrist | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
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| stomach ache | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| vasovagal event | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
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