Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01502410 · ADVERSE EVENTS

Adverse events

Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer · Source last updated 2018-06-26

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
0%

SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Only Grade 3 and higher Adverse Events were collected/assessed in this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1 Relapsed/Refractory Rhabdomyosarcoma

Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

4 / 105 / 10Not reported / Not reported
Group 2 Relapsed/Refractory Wilms Tumor

Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

3 / 106 / 10Not reported / Not reported

Group identifiers: EG000: Group 1 Relapsed/Refractory Rhabdomyosarcoma · EG001: Group 2 Relapsed/Refractory Wilms Tumor

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Anorexia
  2. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Back pain
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Fatigue
  4. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Musculoskeletal and connective tissue disorder - Other
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Neck pain
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Pain
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Pain in extremity
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Pericardial effusion
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Pleural effusion
  11. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Tumor pain

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Alkaline phosphatase increased
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Atelectasis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Blood bilirubin increased
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Diarrhea
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    term
    Dyspnea
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypoalbuminemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypocalcemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Hypokalemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypophosphatemia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Lipase increased
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Lung infection
Complete source fields
description
SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Only Grade 3 and higher Adverse Events were collected/assessed in this study.
event Groups
  1. description
    Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Group 1 Relapsed/Refractory Rhabdomyosarcoma
  2. description
    Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Group 2 Relapsed/Refractory Wilms Tumor
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Alkaline phosphatase increased
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Atelectasis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Blood bilirubin increased
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Diarrhea
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    term
    Dyspnea
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypoalbuminemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypocalcemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Hypokalemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Hypophosphatemia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Lipase increased
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Lung infection
serious Events
  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Anorexia
  2. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Back pain
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Fatigue
  4. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Musculoskeletal and connective tissue disorder - Other
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Neck pain
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Pain
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Pain in extremity
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    term
    Pericardial effusion
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Pleural effusion
  11. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    term
    Tumor pain

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice