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NCT01193842 · ADVERSE EVENTS

Adverse events

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I: VR-DA-EPOCH, Dose Level 1

Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)

5 / 77 / 72 / 7
Phase I: VR-DA-EPOCH, Dose Level 2

Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)

3 / 76 / 71 / 7
Phase I: VR-CHOP, Dose Level 1

Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.

0 / 22 / 20 / 2
Phase II: VR-DA-EPOCH

Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)

25 / 4543 / 4513 / 45
Phase II: DA-R-EPOCH

Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat

21 / 4643 / 469 / 46

Group identifiers: EG000: Phase I: VR-DA-EPOCH, Dose Level 1 · EG001: Phase I: VR-DA-EPOCH, Dose Level 2 · EG002: Phase I: VR-CHOP, Dose Level 1 · EG003: Phase II: VR-DA-EPOCH · EG004: Phase II: DA-R-EPOCH

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 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      46
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Cardiac Disorders - Other, Specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Pericardial Effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Esophageal Ulcer
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Esophagitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Gastric Hemorrhage

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 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Pericarditis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Sinus Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Watering Eyes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      46
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Anal Mucositis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    term
    Colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      46
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      46
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Dyspepsia
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Phase I: VR-CHOP, Dose Level 1
  4. deaths Num Affected
    13
    deaths Num At Risk
    45
    description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
    id
    EG003
    other Num Affected
    43
    other Num At Risk
    45
    serious Num Affected
    25
    serious Num At Risk
    45
    title
    Phase II: VR-DA-EPOCH
  5. deaths Num Affected
    9
    deaths Num At Risk
    46
    description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat
    id
    EG004
    other Num Affected
    43
    other Num At Risk
    46
    serious Num Affected
    21
    serious Num At Risk
    46
    title
    Phase II: DA-R-EPOCH
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      46
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Pericarditis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Sinus Tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Watering Eyes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      46
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Anal Mucositis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      46
    term
    Colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      46
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      46
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Dyspepsia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      46
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      46
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Cardiac Disorders - Other, Specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Pericardial Effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Colitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      46
    term
    Diarrhea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Esophageal Ulcer
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Esophagitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      46
    term
    Gastric Hemorrhage
time Frame
Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.

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