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The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.
This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period:
Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | The Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 |
|
| Treatment Arm | Experimental | The Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDI | Other | Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c 6 Months Change Between AHCL and MDI | The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). | Baseline and end of 6-month study phase |
| Measure | Description | Time Frame |
|---|---|---|
| TIR Between 70-180 mg/dL | % Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). | 6 months study phase |
| Time in Hyperglycemic Range |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c 6 Months Change Between AHCL and MDI | The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | Baseline and end of 6-month study phase |
| TIR Between 70-180 mg/dL |
Inclusion Criteria:
Subject is age ≥ 18 years old at time of screening
Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation
On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening
Subject has been followed and treated by the investigator at this investigational site for at least 3 months prior to screening and subject has already undergone local educational therapeutic programs.
Subject is using:
Subject has a glycosylated hemoglobin (HbA1c) ≥ 8.0% (64 mmol/mol) at time of screening visit (as processed by a Central Lab).
Subject is willing to take or switch to one of the following insulins:
Subject must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 8 units and a maximum of 250 units.
Subject is willing to upload data from the study pump and meter, must have Internet access and a compatible computer system that meets the requirements for uploading the study pump data at home.
Subject is willing and able to sign and date informed consent, comply with all study procedures and wear all study devices, as required during the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz | Besançon | France | ||||
| CHU de Bordeaux - Hôpital Saint André |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37801658 | Derived | Jendle J, Buompensiere MI, Ozdemir Saltik AZ, de Portu S, Smith-Palmer J, Pollock RF, Cohen O. A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2023 Dec;25(12):864-876. doi: 10.1089/dia.2023.0297. | |
| 37551542 |
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122 adults with type 1 diabetes consented to participate in the study. Of them, 19 subjects are Screen Failure. After 8 patients early exited before randomization, 95 (82 in Cohort A, 13 in Cohort B) subjects were randomized in study phase.
Date of first subject enrollment: 13-JUL-2020, Date of last subject visit (of study phase): 02-DEC-2021 Date of last subject visit (of continuation phase): 30-MAY-2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - Treatment Arm | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL. |
| FG001 | Cohort A - Control Arm | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL. |
| FG002 | Cohort B - Treatment Arm | In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL. |
| FG003 | Cohort B - Control Arm | In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. In continuation phase, subjects started using AHCL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Phase |
|
| ||||||||||||||||||
| Continuation Phase |
|
All Subjects Randomized to Corresponding Group
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - Treatment Arm | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL. |
| BG001 | Cohort A - Control Arm |
| 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 | HbA1c 6 Months Change Between AHCL and MDI | The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). | Study phase: 82 subjects in Cohort A. 74 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | Baseline and end of 6-month study phase |
|
4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
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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 | Cohort A Run-in Phase | Subjects were using MDI with Flash Glucose Monitoring (FGM). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Javier Castaneda | Medtronic Diabetes | +31 433566566 | javier.castaneda@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2020 | Nov 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Study Phase | Jun 8, 2021 | Nov 30, 2022 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Continuation Phase | May 17, 2022 | Jan 19, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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There will be 2 Cohort for this study:
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| AHCL | Device | Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0. Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment. |
|
% Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). |
| 6 months study phase |
| Hypoglycemic Events | Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A) | 6 months study phase |
% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).
| 6 months study phase |
| Time in Hyperglycemic Range | % Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | 6 months study phase |
| Hypoglycemic Events | Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | 6 months study phase |
| HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A) | End of 6-month study phase and end of 6-month continuation phase |
| HbA1c 12 Months Change Between Groups | The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort A) | Baseline through the end of 6-month continuation phase (a total of 12 months) |
| HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B). | End of 6-month study phase and end of 6-month continuation phase |
| HbA1c 12 Months Change Between Groups | The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort B). | Baseline through the end of 6-month continuation phase (a total of 12 months). |
| Bordeaux |
| France |
| CHU Caen | Caen | France |
| Hospices Civils de Lyon (DIAB-e CARE) | Lyon | France |
| APM - Hôpital de la Conception | Marseille | France |
| Hospital Civil | Strasbourg | France |
| Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa | Bergheim | Germany |
| Zentrum für Diabetologie Bergedorf | Hamburg | Germany |
| Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis | Lage | Germany |
| Medical Center am Clemenshospital Dr. Winfried Keuthage | Münster | Germany |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital | Cambridge | United Kingdom |
| Harrogate and District Hospital - NHS Foundation Trust | Harrogate | United Kingdom |
| University Hospitals of Leicester NHS Trust Leicester General Hospital | Leicester | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | United Kingdom |
| Derived |
| Edd SN, Castaneda J, Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, Cellot J, de Portu S, Vorrink L, Shin J, van den Heuvel T, Cohen O; ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2023 Nov;25(11):3212-3222. doi: 10.1111/dom.15217. Epub 2023 Aug 8. |
| 36058207 | Derived | Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1. |
| 35110310 | Derived | de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL. |
| BG002 | Cohort B - Treatment Arm | In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL. |
| BG003 | Cohort B - Control Arm | In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. In continuation phase, subjects started using AHCL. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | Percentage |
|
|
|
|
| Secondary | TIR Between 70-180 mg/dL | % Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). | Study phase: 82 subjects in Cohort A. 67 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of Time | 6 months study phase |
|
|
|
|
| Secondary | Time in Hyperglycemic Range | % Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A). | Study phase: 82 subjects in Cohort A. 67 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of Time | 6 months study phase |
|
|
|
|
| Secondary | Hypoglycemic Events | Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A) | Study phase: 82 subjects in Cohort A. 67 subjects have available measurements. | Posted | Mean | Standard Error | Events per week | 6 months study phase |
|
|
|
|
| Other Pre-specified | HbA1c 6 Months Change Between AHCL and MDI | The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | Study phase: 13 subjects in Cohort B. 12 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | Baseline and end of 6-month study phase |
|
|
|
|
| Other Pre-specified | TIR Between 70-180 mg/dL | % Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | Study phase: 13 subjects in Cohort B. 13 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of Time | 6 months study phase |
|
|
|
|
| Other Pre-specified | Time in Hyperglycemic Range | % Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | Study phase: 13 subjects in Cohort B. 13 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of Time | 6 months study phase |
|
|
|
|
| Other Pre-specified | Hypoglycemic Events | Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B). | Study phase: 13 subjects in Cohort B. 13 subjects have available measurements. | Posted | Mean | Standard Error | Events per week | 6 months study phase |
|
|
|
|
| Other Pre-specified | HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A) | Continuation phase: 36 subjects in Cohort A Treatment Arm. 33 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | End of 6-month study phase and end of 6-month continuation phase |
|
|
|
| Other Pre-specified | HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A) | Continuation phase: 38 subjects in Cohort A Control Arm. 31 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | End of 6-month study phase and end of 6-month continuation phase |
|
|
|
| Other Pre-specified | HbA1c 12 Months Change Between Groups | The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort A) | Overall study: 82 subjects in Cohort A. 66 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | Baseline through the end of 6-month continuation phase (a total of 12 months) |
|
|
|
| Other Pre-specified | HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B). | Continuation phase: 8 subjects in Cohort B Treatment Arm. 5 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | End of 6-month study phase and end of 6-month continuation phase |
|
|
|
| Other Pre-specified | HbA1c 6 Months Change Within Group | The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B). | Continuation phase: 5 subjects in Cohort B Control Arm. 3 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | End of 6-month study phase and end of 6-month continuation phase |
|
|
|
| Other Pre-specified | HbA1c 12 Months Change Between Groups | The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort B). | Overall study: 13 subjects in Cohort B. 9 subjects have available measurements. | Posted | Mean | Standard Error | Percentage of HbA1c | Baseline through the end of 6-month continuation phase (a total of 12 months). |
|
|
|
| 0 |
| 105 |
| 1 |
| 105 |
| 21 |
| 105 |
| EG001 | Cohort B Run-in Phase | Subjects were using MDI + Real-Time CGM. | 0 | 17 | 1 | 17 | 1 | 17 |
| EG002 | Cohort A - Treatment Arm Study Phase | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). | 0 | 41 | 1 | 41 | 19 | 41 |
| EG003 | Cohort A - Control Arm Study Phase | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. | 0 | 41 | 1 | 41 | 18 | 41 |
| EG004 | Cohort B - Treatment Arm Study Phase | In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). | 0 | 8 | 1 | 8 | 2 | 8 |
| EG005 | Cohort B - Control Arm Study Phase | In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG006 | All Patients Continuation Phase | All subjects were using AHCL in continuation phase. | 0 | 88 | 2 | 88 | 31 | 88 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Adrenal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA25.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Catheter site mass | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Immunisation reaction | Immune system disorders | MedDRA25.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Infusion site nodule | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Infusion site rash | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA25.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site bruise | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site erythema | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site haemorrhage | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site irritation | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site pruritus | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site rash | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Medical device site reaction | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA25.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Viral rhinitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Viral sinusitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|