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NCT02487095 · ADVERSE EVENTS

Adverse events

Trial of Topotecan With VX-970 (M6620), an ATR Kinase Inhibitor, in Small Cell Cancers and Extrapulmonary Small Cell Cancers · Source last updated 2025-04-13

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
Date treatment consent signed to date off study, approximately 9 months and 9 days for Ph I DL1, 42 months and 12 days for Ph I DL2, 15 months and 9 days for Ph I DL3, 17 months and 9 days for Ph I DL4, and 43 months and 22 days for Ph II DL4.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5

Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5

3 / 66 / 65 / 6
Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

4 / 66 / 66 / 6
Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5

3 / 33 / 33 / 3
Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5

Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5

5 / 66 / 65 / 6
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose

Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose. 26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group.

25 / 4141 / 4135 / 41

Group identifiers: EG000: Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5 · EG001: Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5 · EG002: Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5 · EG003: Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5 · EG004: Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Catheter related infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      41
      num Events
      6
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Dyspnea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Febrile neutropenia

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      41
      num Events
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      41
      num Events
      6
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      41
      num Events
      48
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      5
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      41
      num Events
      76
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Allergic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      41
      num Events
      8
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
      num Events
      38
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
      num Events
      78
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      37
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      6
      num Events
      53
    5. group Id
      EG004
      num Affected
      39
      num At Risk
      41
      num Events
      251
    term
    Anemia
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Phase I Dose Level (DL) 1 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 5
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase I DL1 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 5
  2. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    Phase I Dose Level (DL) 2 Topotecan 1mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase I DL2 Topotecan 1mg/m^2 Intravenous (IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Phase I Dose Level (DL) 3 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 140mg/m\^2 IV on day 2, 5
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Phase I DL3 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 140mg/m^2 IV on Day 2, 5
  4. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Phase I Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Phase I DL4 Topotecan 1.25mg/m^2 Intravenous(IV) (Days 1-5); VX970 (M6620) 210mg/m^2 IV on Day 2, 5
  5. deaths Num Affected
    35
    deaths Num At Risk
    41
    description
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose. 26 participants with small cell lung cancer (SCLC) and 15 with extrapulmonary small cell cancer (EPSCC) are included in this Arm/Group.
    id
    EG004
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    25
    serious Num At Risk
    41
    title
    Phase II Dose Level (DL) 4 Topotecan 1.25mg/m^2; VX970 (M6620) 210mg/m^2 Recommended Phase II Dose
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      41
      num Events
      18
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      41
      num Events
      6
    term
    Activated partial thromboplastin time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      41
      num Events
      48
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      5
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      41
      num Events
      76
    term
    Alkaline phosphatase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Allergic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Allergic rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      41
      num Events
      8
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      6
      num Events
      38
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
      num Events
      78
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      37
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      6
      num Events
      53
    5. group Id
      EG004
      num Affected
      39
      num At Risk
      41
      num Events
      251
    term
    Anemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Catheter related infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      41
      num Events
      6
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Dyspnea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Edema limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Febrile neutropenia
time Frame
Date treatment consent signed to date off study, approximately 9 months and 9 days for Ph I DL1, 42 months and 12 days for Ph I DL2, 15 months and 9 days for Ph I DL3, 17 months and 9 days for Ph I DL4, and 43 months and 22 days for Ph II DL4.

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