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NCT03280264 · ADVERSE EVENTS

Adverse events

Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism · Source last updated 2021-05-27

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
up to 52week
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
KHK7580 (2-24 mg)

KHK7580 was orally administered daily for up to week 52.

3 / 1818 / 180 / 18

Group identifiers: EG000: KHK7580 (2-24 mg)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    enterocolitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    urinary tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    uterine cancer

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 ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Iron deficiency anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Nephrogenic anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Cataract cortical
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Ocular hyperaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal pain lower
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dental caries
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Enterocolitis
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    KHK7580 was orally administered daily for up to week 52.
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    3
    serious Num At Risk
    18
    title
    KHK7580 (2-24 mg)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Iron deficiency anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Nephrogenic anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Cataract cortical
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Ocular hyperaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal pain lower
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dental caries
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Enterocolitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    enterocolitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    urinary tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA ver21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    uterine cancer
time Frame
up to 52week

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Preserved source evidence · Not medical advice