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NCT00105443 · ADVERSE EVENTS

Adverse events

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2014-10-31

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
Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
Other-event reporting threshold
5%

RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)

Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.

153 / 297275 / 297Not reported / Not reported
Placebo Arm Double-Blind Phase (Interim Data Only)

Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.

164 / 302259 / 302Not reported / Not reported
Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)

Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.

191 / 297281 / 297Not reported / Not reported
Placebo Arm, Complete Double-Blind Phase

Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.

185 / 302271 / 302Not reported / Not reported
Subjects Switching From Placebo to Sorafenib (Open Label Only)

Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.

26 / 4743 / 47Not reported / Not reported

Group identifiers: EG000: Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only) · EG001: Placebo Arm Double-Blind Phase (Interim Data Only) · EG002: Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase) · EG003: Placebo Arm, Complete Double-Blind Phase · EG004: Subjects Switching From Placebo to Sorafenib (Open Label Only)

Serious adverse events

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

  1. assessment Type
    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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    neutrophils
  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
      8
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    hemoglobin
  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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    leukocytes
  4. 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
      297
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    supraventricular arrhythmia, atrial fibrillation
  5. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    conduction abnormality, av block - first degree
  6. 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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    supraventricular arrhythmia, sinus tachycardia
  7. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    ventricular arrhythmia, ventricular 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
      0
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    ventricular arrhythmia, ventricular tachycardia
  9. 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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    inr
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    left ventricular diastolic dysfunction
  11. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    term
    cardiac ischemia/infarction

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
      25
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      47
    term
    hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      47
    term
    hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      47
    term
    fever
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      47
    term
    insomnia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      133
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      145
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      144
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      47
    term
    fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      47
    term
    weight loss
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      56
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      47
    term
    anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      47
    term
    ascites
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      47
    term
    constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      158
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      166
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      82
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      47
    term
    diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    term
    heartburn
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    mucositis (functional/symptomatic), oral cavity
Complete source fields
description
RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
event Groups
  1. description
    Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
    id
    EG000
    other Num Affected
    275
    other Num At Risk
    297
    serious Num Affected
    153
    serious Num At Risk
    297
    title
    Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)
  2. description
    Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.
    id
    EG001
    other Num Affected
    259
    other Num At Risk
    302
    serious Num Affected
    164
    serious Num At Risk
    302
    title
    Placebo Arm Double-Blind Phase (Interim Data Only)
  3. description
    Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
    id
    EG002
    other Num Affected
    281
    other Num At Risk
    297
    serious Num Affected
    191
    serious Num At Risk
    297
    title
    Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)
  4. description
    Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section.
    id
    EG003
    other Num Affected
    271
    other Num At Risk
    302
    serious Num Affected
    185
    serious Num At Risk
    302
    title
    Placebo Arm, Complete Double-Blind Phase
  5. description
    Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
    id
    EG004
    other Num Affected
    43
    other Num At Risk
    47
    serious Num Affected
    26
    serious Num At Risk
    47
    title
    Subjects Switching From Placebo to Sorafenib (Open Label Only)
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
      25
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      47
    term
    hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      47
    term
    hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      47
    term
    fever
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      47
    term
    insomnia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      133
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      145
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      144
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      47
    term
    fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      47
    term
    weight loss
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      56
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      47
    term
    anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      47
    term
    ascites
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      47
    term
    constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      158
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      166
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      82
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      47
    term
    diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    term
    heartburn
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    mucositis (functional/symptomatic), oral cavity
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
      1
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    neutrophils
  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
      8
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    hemoglobin
  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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    leukocytes
  4. 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
      297
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    supraventricular arrhythmia, atrial fibrillation
  5. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    conduction abnormality, av block - first degree
  6. 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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    supraventricular arrhythmia, sinus tachycardia
  7. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    ventricular arrhythmia, ventricular 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
      0
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    ventricular arrhythmia, ventricular tachycardia
  9. 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
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    inr
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    left ventricular diastolic dysfunction
  11. 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
      297
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      47
    term
    hypertension
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI-CTCAE v. 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      297
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      302
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      297
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      302
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      47
    term
    cardiac ischemia/infarction
time Frame
Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)

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