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NCT04233034 · ADVERSE EVENTS

Adverse events

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes · Source last updated 2024-11-27

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HCL and Verapamil

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

3 / 2220 / 220 / 22
HCL and Placebo

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

1 / 2016 / 200 / 20
Non-HCL and Verapamil

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

1 / 2519 / 250 / 25
Non-HCL and Placebo

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

3 / 2114 / 210 / 21
HCL Only

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

1 / 1918 / 190 / 19
Non-HCL Only

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

0 / 64 / 60 / 6

Group identifiers: EG000: HCL and Verapamil · EG001: HCL and Placebo · EG002: Non-HCL and Verapamil · EG003: Non-HCL and Placebo · EG004: HCL Only · EG005: Non-HCL Only

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Suicidal Ideation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Depression
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Asthma
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoglycemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diabetic Ketoacidosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Ketosis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Swollen Glands
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    2nd Degree Heart Block
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac Arrhythmia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    1st Degree Heart Block
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Premature Ventricular Contractions
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Ear Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Otitis Externa
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Otitis Media Acute
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain in Ear
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      22
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperglycemia
Complete source fields
event Groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Swollen Glands
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    2nd Degree Heart Block
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac Arrhythmia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    1st Degree Heart Block
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Premature Ventricular Contractions
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Ear Infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Otitis Externa
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Otitis Media Acute
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain in Ear
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      22
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      19
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperglycemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Suicidal Ideation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Depression
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Asthma
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoglycemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diabetic Ketoacidosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. 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.

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