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NCT00410124 · ADVERSE EVENTS

Adverse events

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib · Source last updated 2013-01-15

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
5%

The Safety population consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Randomized to RAD001+ BSC ( Blinded + Open Label)

The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.

135 / 274261 / 274Not reported / Not reported
Randomized to Placebo + BSC (Open Label)

With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.

60 / 111106 / 111Not reported / Not reported
Randomized to Placebo + BSC (Double Blind Only)

Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.

17 / 2623 / 26Not reported / Not reported

Group identifiers: EG000: Randomized to RAD001+ BSC ( Blinded + Open Label) · EG001: Randomized to Placebo + BSC (Open Label) · EG002: Randomized to Placebo + BSC (Double Blind Only)

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
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Bone marrow reticulin fibrosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Haemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Aortic valve incompetence
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Pericardial effusion

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
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Aphthous stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      26
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      26
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      26
    term
    Nausea
Complete source fields
description
The Safety population consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received.
event Groups
  1. description
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    EG000
    other Num Affected
    261
    other Num At Risk
    274
    serious Num Affected
    135
    serious Num At Risk
    274
    title
    Randomized to RAD001+ BSC ( Blinded + Open Label)
  2. description
    With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    EG001
    other Num Affected
    106
    other Num At Risk
    111
    serious Num Affected
    60
    serious Num At Risk
    111
    title
    Randomized to Placebo + BSC (Open Label)
  3. description
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
    id
    EG002
    other Num Affected
    23
    other Num At Risk
    26
    serious Num Affected
    17
    serious Num At Risk
    26
    title
    Randomized to Placebo + BSC (Double Blind Only)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Aphthous stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      26
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      26
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      26
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      26
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Bone marrow reticulin fibrosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Haemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Aortic valve incompetence
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      26
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      274
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      26
    term
    Pericardial effusion

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Preserved source evidence · Not medical advice