Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01849874 · ADVERSE EVENTS

Adverse events

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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
From the first dose of study intervention until 30 days after the last dose (up to 9 years)
Other-event reporting threshold
5%

Same event might appear as AE and serious AE, what was presented are distinct events. Event might be categorized as serious in 1 participant and as non-serious in another or 1 participant might have experienced both during study. Safety set included all participants who received at least 1 dose of study intervention and have at least 1 post-treatment assessment, including death. Crossover set all-cause mortality and AEs were not collected given the early stopping of the crossover period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MEK162

Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.

126 / 227226 / 22789 / 227
Physician's Choice

Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.

31 / 106105 / 10642 / 106

Group identifiers: EG000: MEK162 · EG001: Physician's Choice

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 Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    term
    Small intestinal obstruction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    term
    Intestinal obstruction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Colonic obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Large intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Subileus

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      106
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      106
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      106
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      106
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      106
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      106
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      106
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      106
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      106
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Ascites
Complete source fields
description
Same event might appear as AE and serious AE, what was presented are distinct events. Event might be categorized as serious in 1 participant and as non-serious in another or 1 participant might have experienced both during study. Safety set included all participants who received at least 1 dose of study intervention and have at least 1 post-treatment assessment, including death. Crossover set all-cause mortality and AEs were not collected given the early stopping of the crossover period.
event Groups
  1. deaths Num Affected
    89
    deaths Num At Risk
    227
    description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    EG000
    other Num Affected
    226
    other Num At Risk
    227
    serious Num Affected
    126
    serious Num At Risk
    227
    title
    MEK162
  2. deaths Num Affected
    42
    deaths Num At Risk
    106
    description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    106
    serious Num Affected
    31
    serious Num At Risk
    106
    title
    Physician's Choice
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      106
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      106
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      106
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      106
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      106
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      106
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      106
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      106
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      106
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Abdominal pain upper
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Ascites
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    term
    Small intestinal obstruction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    term
    Intestinal obstruction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      106
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Colonic obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Large intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 16.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Subileus
time Frame
From the first dose of study intervention until 30 days after the last dose (up to 9 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice