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NCT00101413 · ADVERSE EVENTS

Adverse events

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC) · Source last updated 2013-10-30

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
AE data were collected from Apr 2004 to Apr 2008
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sorafenib

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

28 / 5251 / 52Not reported / Not reported

Group identifiers: EG000: Sorafenib

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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrythmia - other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    Cardiac general - other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hypotension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    Death not associated with ctcae term, disease progression nos
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    term
    Constitutional symptoms - other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Fistula, GI, esophagus

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
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
    term
    Hypertension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      52
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Weight loss
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Fever
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      52
    term
    Hand-foot skin reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      52
    term
    Dermatology - other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
    term
    Dry skin
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Pruritus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
    term
    Rash/desquamation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      52
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      52
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      52
    term
    Nausea
Complete source fields
event Groups
  1. description
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    52
    serious Num Affected
    28
    serious Num At Risk
    52
    title
    Sorafenib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
    term
    Hypertension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      52
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Weight loss
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Fever
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      52
    term
    Hand-foot skin reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      52
    term
    Dermatology - other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      52
    term
    Dry skin
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Pruritus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
    term
    Rash/desquamation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      52
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      52
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      52
    term
    Nausea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Platelets
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrythmia - other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    Cardiac general - other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Hypotension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    Death not associated with ctcae term, disease progression nos
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    term
    Constitutional symptoms - other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTC 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Fistula, GI, esophagus
time Frame
AE data were collected from Apr 2004 to Apr 2008

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