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NCT01037790 · ADVERSE EVENTS

Adverse events

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer · Source last updated 2021-03-11

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
10years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1

Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day

1 / 6340 / 630 / 63
Arm 2

Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day

10 / 1818 / 180 / 18
Arm 3

Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day

11 / 1919 / 191 / 19
Arm 4

Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day

10 / 3025 / 300 / 30
Arm 5

Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day

4 / 1111 / 111 / 11

Group identifiers: EG000: Arm 1 · EG001: Arm 2 · EG002: Arm 3 · EG003: Arm 4 · EG004: Arm 5

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      19
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bowel obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    elevated alk phos
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    elavated ALT
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    elevated AST
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    GI bleed
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      19
      num Events
      4
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      30
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      19
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    mucositis

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      63
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    aches
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    acne
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      63
      num Events
      34
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      19
      num Events
      7
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      30
      num Events
      7
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      19
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    arthalgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    belching
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bloating
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      19
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    blurred vision
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bowel obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bruising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    burning eyes
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    63
    description
    Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    63
    serious Num Affected
    1
    serious Num At Risk
    63
    title
    Arm 1
  2. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    10
    serious Num At Risk
    18
    title
    Arm 2
  3. deaths Num Affected
    1
    deaths Num At Risk
    19
    description
    Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    11
    serious Num At Risk
    19
    title
    Arm 3
  4. deaths Num Affected
    0
    deaths Num At Risk
    30
    description
    Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    EG003
    other Num Affected
    25
    other Num At Risk
    30
    serious Num Affected
    10
    serious Num At Risk
    30
    title
    Arm 4
  5. deaths Num Affected
    1
    deaths Num At Risk
    11
    description
    Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Arm 5
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      63
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    aches
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    acne
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      63
      num Events
      34
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      19
      num Events
      7
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      30
      num Events
      7
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      63
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      19
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      30
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    arthalgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    belching
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bloating
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      19
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    blurred vision
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bowel obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bruising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    burning eyes
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      19
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    bowel obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    elevated alk phos
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    elavated ALT
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    elevated AST
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    GI bleed
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      19
      num Events
      4
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      30
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      19
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    lymphopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    mucositis
time Frame
10years

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Preserved source evidence · Not medical advice