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NCT00073307 · ADVERSE EVENTS

Adverse events

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer · Source last updated 2014-02-06

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
In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.
Other-event reporting threshold
5%

DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sorafenib (Nexavar, BAY43-9006)-31May2005 DB

Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005

154 / 451407 / 451Not reported / Not reported
Placebo-31May2005 DB

Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]

110 / 451346 / 451Not reported / Not reported
Sorafenib (Nexavar, BAY43-9006)-30Jun2008

Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.

245 / 452425 / 452Not reported / Not reported
Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008

Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of \~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008

124 / 216200 / 216Not reported / Not reported

Group identifiers: EG000: Sorafenib (Nexavar, BAY43-9006)-31May2005 DB · EG001: Placebo-31May2005 DB · EG002: Sorafenib (Nexavar, BAY43-9006)-30Jun2008 · EG003: Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008

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-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      216
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Blood - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Platelets
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    DIC
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Edema: Limb
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Lymphatics - Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Supraventricular Arrhythmia, Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Supraventricular Arrhythmia,supraventricular Arrhythmia NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Cardiac Arrhythmia - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Supraventricular Arrhythmia, ATrial Tach/Paroxysmal AT
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Supraventricular Arrhythmia, Sinus Tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Cardiac Arrest

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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      216
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      216
    term
    Edema: Limb
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      101
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      216
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      58
      num At Risk
      216
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      79
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      216
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      195
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      244
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      118
      num At Risk
      216
    term
    Diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      216
    term
    Heartburn
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      216
    term
    Mucositis (Functional/Symptomatic), Oral Cavity
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      216
    term
    Mucositis (Clinical Exam), Oral Cavity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      121
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      216
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      216
    term
    GI - Other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      216
    term
    Vomiting
Complete source fields
description
DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)
event Groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
    id
    EG000
    other Num Affected
    407
    other Num At Risk
    451
    serious Num Affected
    154
    serious Num At Risk
    451
    title
    Sorafenib (Nexavar, BAY43-9006)-31May2005 DB
  2. description
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    EG001
    other Num Affected
    346
    other Num At Risk
    451
    serious Num Affected
    110
    serious Num At Risk
    451
    title
    Placebo-31May2005 DB
  3. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
    id
    EG002
    other Num Affected
    425
    other Num At Risk
    452
    serious Num Affected
    245
    serious Num At Risk
    452
    title
    Sorafenib (Nexavar, BAY43-9006)-30Jun2008
  4. description
    Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of \~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
    id
    EG003
    other Num Affected
    200
    other Num At Risk
    216
    serious Num Affected
    124
    serious Num At Risk
    216
    title
    Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      216
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      216
    term
    Edema: Limb
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      101
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      216
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      58
      num At Risk
      216
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      79
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      216
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      195
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      244
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      118
      num At Risk
      216
    term
    Diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      216
    term
    Heartburn
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      216
    term
    Mucositis (Functional/Symptomatic), Oral Cavity
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      216
    term
    Mucositis (Clinical Exam), Oral Cavity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      121
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      216
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      216
    term
    GI - Other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      216
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      216
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Blood - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Platelets
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    DIC
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Edema: Limb
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Lymphatics - Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Supraventricular Arrhythmia, Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Supraventricular Arrhythmia,supraventricular Arrhythmia NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Cardiac Arrhythmia - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      216
    term
    Supraventricular Arrhythmia, ATrial Tach/Paroxysmal AT
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Supraventricular Arrhythmia, Sinus Tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      451
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      451
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      452
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      216
    term
    Cardiac Arrest
time Frame
In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.

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

Preserved source evidence · Not medical advice