Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01445080 · ADVERSE EVENTS

Adverse events

Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia · Source last updated 2021-02-02

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
Up to 2 years
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2

Patients receive oral sorafenib 105 mg/m\^2 every 12 hours

7 / 77 / 77 / 7
Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2

Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.

5 / 55 / 55 / 5
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2

Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.

12 / 1212 / 1212 / 12
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.

8 / 88 / 88 / 8
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2

Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.

2 / 42 / 42 / 4
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2

Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.

9 / 99 / 99 / 9
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.

2 / 22 / 22 / 2
Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2

Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.

5 / 55 / 55 / 5
PK Cohort Expanded: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.

18 / 1818 / 1818 / 18

Group identifiers: EG000: Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2 · EG001: Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2 · EG002: Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2 · EG003: Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2 · EG004: Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2 · EG005: Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2 · EG006: Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2 · EG007: Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2 · EG008: PK Cohort Expanded: BAY 43-9006 200 mg/m^2

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anaphylaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Aspartate aminotransferase increased

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      18
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Alkalosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Allergic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      18
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anal mucositis
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    7
    serious Num At Risk
    7
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
  3. deaths Num Affected
    12
    deaths Num At Risk
    12
    description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    12
    serious Num At Risk
    12
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  4. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
    id
    EG003
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  5. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  6. deaths Num Affected
    9
    deaths Num At Risk
    9
    description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    9
    serious Num At Risk
    9
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  7. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  8. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
  9. deaths Num Affected
    18
    deaths Num At Risk
    18
    description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    EG008
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    18
    serious Num At Risk
    18
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      18
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Alkalosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Allergic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      18
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anal mucositis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anaphylaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      18
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      18
    term
    Aspartate aminotransferase increased
time Frame
Up to 2 years

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

Preserved source evidence · Not medical advice