Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01604772 · ADVERSE EVENTS

Adverse events

Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma · Source last updated 2019-05-01

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Akt Inhibitor MK2206)

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: 150 mg given PO

2 / 1616 / 16Not reported / Not reported

Group identifiers: EG000: Treatment (Akt Inhibitor MK2206)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Esophageal hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
      num Events
      12
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
      num Events
      14
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      3
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eye disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      10
    term
    Cheilitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      10
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
      num Events
      10
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Dyspepsia
Complete source fields
event Groups
  1. description
    Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: 150 mg given PO
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    2
    serious Num At Risk
    16
    title
    Treatment (Akt Inhibitor MK2206)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
      num Events
      12
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
      num Events
      14
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      3
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eye disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      10
    term
    Cheilitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      10
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
      num Events
      10
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Esophageal hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypotension

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice