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NCT03233724 · ADVERSE EVENTS

Adverse events

Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas · Source last updated 2023-05-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Date treatment consent signed to date off study, approximately 2 months/10 days, 10 months/29 days, 20 months/30 days for the first, second and third group respectively.
Other-event reporting threshold
0%

1/9 participants did not receive any therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)

Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level 1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT) q week with Pembrolizumab infusion q3weeks

2 / 22 / 20 / 2
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)

Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level -1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT) q week. Participants received Pembrolizumab infusion q3weeks.

1 / 22 / 20 / 2
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks

Phase 1, Arm 1, Dose Escalation, Revised Dose Level 1. Participants received Decitabine 0.21 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.

2 / 44 / 40 / 4
Decitabine 0.17mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks

Phase 1, Arm 1, Dose Escalation, Revised Dose Level -1. Participants received Decitabine 0.17 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.

0 / 00 / 00 / 0

Group identifiers: EG000: Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT) · EG001: Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT) · EG002: Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks · EG003: Decitabine 0.17mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks

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
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyponatremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    White blood cell decreased

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
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bronchopulmonary hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyperkalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hypoalbuminemia
Complete source fields
description
1/9 participants did not receive any therapy.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level 1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT) q week with Pembrolizumab infusion q3weeks
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)
  2. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level -1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT) q week. Participants received Pembrolizumab infusion q3weeks.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)
  3. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Phase 1, Arm 1, Dose Escalation, Revised Dose Level 1. Participants received Decitabine 0.21 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks
  4. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Phase 1, Arm 1, Dose Escalation, Revised Dose Level -1. Participants received Decitabine 0.17 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Decitabine 0.17mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bronchopulmonary hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Creatinine increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyperkalemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hypoalbuminemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Hyponatremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Lymphocyte count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Neutrophil count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    White blood cell decreased
time Frame
Date treatment consent signed to date off study, approximately 2 months/10 days, 10 months/29 days, 20 months/30 days for the first, second and third group respectively.

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Preserved source evidence · Not medical advice