Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01524783 · ADVERSE EVENTS

Adverse events

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) · Source last updated 2021-08-05

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 events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Other-event reporting threshold
5%

Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Everolimus+BSC (Throughout Study)

Participants received everolimus 10 mg once daily plus BSC throughout the study

93 / 202197 / 20210 / 202
Everolimus +BSC (Crossover)

Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC

1 / 66 / 60 / 6
Everolimus+BSC (All)

All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)

94 / 208203 / 20810 / 208
Placebo+BSC (Blinded Period)

Participants received matching placebo once daily plus best supportive care (BSC) during the blinded period.

21 / 9881 / 985 / 98

Group identifiers: EG000: Everolimus+BSC (Throughout Study) · EG001: Everolimus +BSC (Crossover) · EG002: Everolimus+BSC (All) · EG003: Placebo+BSC (Blinded Period)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiovascular disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Myocardial ischaemia

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 (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Deafness
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Carcinoid syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Blindness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Visual impairment
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Abdominal discomfort
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      98
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      98
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Aphthous ulcer
Complete source fields
description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
event Groups
  1. deaths Num Affected
    10
    deaths Num At Risk
    202
    description
    Participants received everolimus 10 mg once daily plus BSC throughout the study
    id
    EG000
    other Num Affected
    197
    other Num At Risk
    202
    serious Num Affected
    93
    serious Num At Risk
    202
    title
    Everolimus+BSC (Throughout Study)
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Everolimus +BSC (Crossover)
  3. deaths Num Affected
    10
    deaths Num At Risk
    208
    description
    All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
    id
    EG002
    other Num Affected
    203
    other Num At Risk
    208
    serious Num Affected
    94
    serious Num At Risk
    208
    title
    Everolimus+BSC (All)
  4. deaths Num Affected
    5
    deaths Num At Risk
    98
    description
    Participants received matching placebo once daily plus best supportive care (BSC) during the blinded period.
    id
    EG003
    other Num Affected
    81
    other Num At Risk
    98
    serious Num Affected
    21
    serious Num At Risk
    98
    title
    Placebo+BSC (Blinded Period)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Deafness
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Carcinoid syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Blindness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Visual impairment
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      98
    term
    Abdominal discomfort
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      98
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      98
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      98
    term
    Aphthous ulcer
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      98
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Cardiovascular disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (23.0.)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      202
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      208
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      98
    term
    Myocardial ischaemia
time Frame
Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years

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

Preserved source evidence · Not medical advice