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NCT01532687 · ADVERSE EVENTS

Adverse events

Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma · Source last updated 2021-09-27

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
Adverse events were collected up 30 days after the last dose of study drugs while participant was in that Arm/Group. All-Cause Mortality was assessed up to 3 years. For SAEs and OAEs, the Gem+Pazo group was assessed up to 32.1 months; Gem+Placebo participants were assessed up to 36.0 months (30 days after progression). If Gem+Placebo participants crossed over to open-label Pazo after progression, any additional AEs were collected under the crossover arm (up to 16.6 months).
Other-event reporting threshold
4%

All Serious Adverse Events (SAEs) are reported, irrespective of grade or attribution. For other Adverse Events (AEs), only those grade 3 or higher are collected with a threshold set at 3.5% within any arm. AEs and SAEs are assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Assessments are made by laboratory tests, physical exam, and other clinical measurements (e.g. ECGs, radiological scans, vital signs, etc.)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO

8 / 2925 / 2923 / 29
Gemcitabine Hydrochloride Plus Placebo

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression, are unblinded and found randomized to placebo arm may crossover to receive open-label pazopanib hydrochloride PO daily. AEs and deaths reported only while participant is in placebo arm/group. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO

6 / 2514 / 2510 / 11
Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib

Patients who progress and found randomized to the placebo arm after unblinding are eligible for receipt of open-label gemcitabine plus pazopanib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. AEs and deaths collected during this treatment period

5 / 149 / 1411 / 14

Group identifiers: EG000: Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride · EG001: Gemcitabine Hydrochloride Plus Placebo · EG002: Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib

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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Cholecystitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Dyspnea
  6. 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
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Gastric perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hepatic failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hypertension
  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
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Pain
  12. 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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Proteinuria

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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Hypoalbuminemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hypophosphatemia
Complete source fields
description
All Serious Adverse Events (SAEs) are reported, irrespective of grade or attribution. For other Adverse Events (AEs), only those grade 3 or higher are collected with a threshold set at 3.5% within any arm. AEs and SAEs are assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Assessments are made by laboratory tests, physical exam, and other clinical measurements (e.g. ECGs, radiological scans, vital signs, etc.)
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    29
    description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    29
    serious Num Affected
    8
    serious Num At Risk
    29
    title
    Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride
  2. deaths Num Affected
    10
    deaths Num At Risk
    11
    description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression, are unblinded and found randomized to placebo arm may crossover to receive open-label pazopanib hydrochloride PO daily. AEs and deaths reported only while participant is in placebo arm/group. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    25
    serious Num Affected
    6
    serious Num At Risk
    25
    title
    Gemcitabine Hydrochloride Plus Placebo
  3. deaths Num Affected
    11
    deaths Num At Risk
    14
    description
    Patients who progress and found randomized to the placebo arm after unblinding are eligible for receipt of open-label gemcitabine plus pazopanib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. AEs and deaths collected during this treatment period
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib
frequency Threshold
4
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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    term
    Hypoalbuminemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hypophosphatemia
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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Cholecystitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Dyspnea
  6. 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
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Gastric perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hepatic failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Hypertension
  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
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    term
    Pain
  12. 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
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    term
    Proteinuria
time Frame
Adverse events were collected up 30 days after the last dose of study drugs while participant was in that Arm/Group. All-Cause Mortality was assessed up to 3 years. For SAEs and OAEs, the Gem+Pazo group was assessed up to 32.1 months; Gem+Placebo participants were assessed up to 36.0 months (30 days after progression). If Gem+Placebo participants crossed over to open-label Pazo after progression, any additional AEs were collected under the crossover arm (up to 16.6 months).

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Preserved source evidence · Not medical advice