Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03697109 · ADVERSE EVENTS

Adverse events

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome · Source last updated 2025-07-16

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
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Relacorilant (OL Phase)

Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

29 / 152147 / 1522 / 152
Relacorilant (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

5 / 3022 / 300 / 30
Placebo (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug

1 / 3227 / 320 / 32

Group identifiers: EG000: Relacorilant (OL Phase) · EG001: Relacorilant (RW Phase) · EG002: Placebo (RW Phase)

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
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bone abscess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    COVID-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    COVID-19 pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Cavernous sinus thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Diverticulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Epididyitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pseudomonal sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Rectal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Sinusitis fungal

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Pain in extremity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Myalgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Muscular weakness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Muscle spasms
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bursitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Vomiting
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    152
    description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    EG000
    other Num Affected
    147
    other Num At Risk
    152
    serious Num Affected
    29
    serious Num At Risk
    152
    title
    Relacorilant (OL Phase)
  2. deaths Num Affected
    0
    deaths Num At Risk
    30
    description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    30
    serious Num Affected
    5
    serious Num At Risk
    30
    title
    Relacorilant (RW Phase)
  3. deaths Num Affected
    0
    deaths Num At Risk
    32
    description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug
    id
    EG002
    other Num Affected
    27
    other Num At Risk
    32
    serious Num Affected
    1
    serious Num At Risk
    32
    title
    Placebo (RW Phase)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Pain in extremity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      32
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Myalgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Muscular weakness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Muscle spasms
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bursitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bone abscess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    COVID-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    COVID-19 pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Cavernous sinus thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Diverticulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Epididyitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Osteomyelitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pseudomonal sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Rectal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Sinusitis fungal
time Frame
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase.

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

Preserved source evidence · Not medical advice