NCT04233034 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Adverse event data where collected during the 52 week RCT phase.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| HCL and Verapamil | 3 / 22 | 20 / 22 | 0 / 22 |
| HCL and Placebo | 1 / 20 | 16 / 20 | 0 / 20 |
| Non-HCL and Verapamil | 1 / 25 | 19 / 25 | 0 / 25 |
| Non-HCL and Placebo | 3 / 21 | 14 / 21 | 0 / 21 |
| HCL Only | 1 / 19 | 18 / 19 | 0 / 19 |
| Non-HCL Only | 0 / 6 | 4 / 6 | 0 / 6 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 22
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Suicidal Ideation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Depression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Asthma
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Hypoglycemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 19
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Diabetic Ketoacidosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Ketosis
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Lymphadenopathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Swollen Glands
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- 2nd Degree Heart Block
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Cardiac Arrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- 1st Degree Heart Block
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Premature Ventricular Contractions
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 19
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Ear Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Otitis Externa
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 19
- num Events
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Otitis Media Acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Pain in Ear
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 22
- num Events
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 19
- num Events
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Hyperglycemia
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 22
- description
- Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil 120mg tablet: verapamil tablet
- id
- EG000
- other Num Affected
- 20
- other Num At Risk
- 22
- serious Num Affected
- 3
- serious Num At Risk
- 22
- title
- HCL and Verapamil
- deaths Num Affected
- 0
- deaths Num At Risk
- 20
- description
- Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy placebo: placebo pill manufactured to mimic verapamil 120mg tablet
- id
- EG001
- other Num Affected
- 16
- other Num At Risk
- 20
- serious Num Affected
- 1
- serious Num At Risk
- 20
- title
- HCL and Placebo
- deaths Num Affected
- 0
- deaths Num At Risk
- 25
- description
- Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] verapamil 120mg tablet: verapamil tablet non-HCL: Usual diabetes care
- id
- EG002
- other Num Affected
- 19
- other Num At Risk
- 25
- serious Num Affected
- 1
- serious Num At Risk
- 25
- title
- Non-HCL and Verapamil
- deaths Num Affected
- 0
- deaths Num At Risk
- 21
- description
- Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care placebo: placebo pill manufactured to mimic verapamil 120mg tablet
- id
- EG003
- other Num Affected
- 14
- other Num At Risk
- 21
- serious Num Affected
- 3
- serious Num At Risk
- 21
- title
- Non-HCL and Placebo
- deaths Num Affected
- 0
- deaths Num At Risk
- 19
- description
- Participants weighing \<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL. Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. HCL: Hybrid Closed Loop Therapy
- id
- EG004
- other Num Affected
- 18
- other Num At Risk
- 19
- serious Num Affected
- 1
- serious Num At Risk
- 19
- title
- HCL Only
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Participants weighing \<30 kg at study enrollment were randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes care or usual care with no HCL. Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. non-HCL: Usual diabetes care
- id
- EG005
- other Num Affected
- 4
- other Num At Risk
- 6
- serious Num Affected
- 0
- serious Num At Risk
- 6
- title
- Non-HCL Only
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Lymphadenopathy
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Swollen Glands
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- 2nd Degree Heart Block
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Cardiac Arrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- 1st Degree Heart Block
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Premature Ventricular Contractions
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 19
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Ear Infection
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Otitis Externa
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 19
- num Events
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Otitis Media Acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Pain in Ear
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 22
- num Events
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 19
- num Events
- 3
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Hyperglycemia
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 22
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Suicidal Ideation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Depression
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Asthma
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 22
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Hypoglycemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 19
- num Events
- 1
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Diabetic Ketoacidosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 22
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 19
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Ketosis
- time Frame
- Adverse event data where collected during the 52 week RCT phase.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle