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NCT03513952 · ADVERSE EVENTS

Adverse events

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma · Source last updated 2024-07-26

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
Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Other-event reporting threshold
5%

Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1 (CYT107, Atezolizumab)

Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM

13 / 1918 / 1911 / 19
Group 2 (Atezolizumab)

Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV

11 / 1919 / 1914 / 21
Safety Run in Phase

Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM

5 / 77 / 76 / 7

Group identifiers: EG000: Group 1 (CYT107, Atezolizumab) · EG001: Group 2 (Atezolizumab) · EG002: Safety Run in Phase

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
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Atrial Flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Myocardial Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Esophageal Obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Pancreatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Small Intestinal Obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Death NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Disease Progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Edema Limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Fatigue

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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    DVT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Hypervolemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Chest Pain - Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Diastolic Dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Heart Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Sinus Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Sinus Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Supraventricular Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Ear Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Right Ear Impaction
Complete source fields
description
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    19
    description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    19
    serious Num Affected
    13
    serious Num At Risk
    19
    title
    Group 1 (CYT107, Atezolizumab)
  2. deaths Num Affected
    14
    deaths Num At Risk
    21
    description
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    11
    serious Num At Risk
    19
    title
    Group 2 (Atezolizumab)
  3. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Safety Run in Phase
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    DVT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Hypervolemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Chest Pain - Cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Diastolic Dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Heart Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Sinus Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Sinus Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Supraventricular Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Ear Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Right Ear Impaction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Atrial Flutter
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Myocardial Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Esophageal Obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Pancreatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Small Intestinal Obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Death NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Disease Progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Edema Limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Fatigue
time Frame
Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.

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Preserved source evidence · Not medical advice