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NCT01515787 · ADVERSE EVENTS

Adverse events

PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery · Source last updated 2024-02-02

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
Up to 5 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1

5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.

10 / 585582 / 58574 / 585
Group 2

surgery: low anterior resection with total mesorectal excision

7 / 543534 / 54367 / 543

Group identifiers: EG000: Group 1 · EG001: Group 2

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
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Cardiac arrest
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Rectal perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      543
      num Events
      2
    term
    Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      585
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Sudden death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Infections and infestations - Oth spec
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Stroke
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Thromboembolic event

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
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      585
      num Events
      168
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      543
      num Events
      106
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      585
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      543
      num Events
      4
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      585
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      585
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      543
      num Events
      2
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      585
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      543
      num Events
      3
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Cardiac arrest
Complete source fields
event Groups
  1. deaths Num Affected
    74
    deaths Num At Risk
    585
    description
    5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
    id
    EG000
    other Num Affected
    582
    other Num At Risk
    585
    serious Num Affected
    10
    serious Num At Risk
    585
    title
    Group 1
  2. deaths Num Affected
    67
    deaths Num At Risk
    543
    description
    surgery: low anterior resection with total mesorectal excision
    id
    EG001
    other Num Affected
    534
    other Num At Risk
    543
    serious Num Affected
    7
    serious Num At Risk
    543
    title
    Group 2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      585
      num Events
      168
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      543
      num Events
      106
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      585
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      543
      num Events
      4
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      585
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      2
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Spleen disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      585
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      543
      num Events
      2
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Asystole
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      585
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      543
      num Events
      3
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Cardiac arrest
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Cardiac arrest
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Rectal perforation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      543
      num Events
      2
    term
    Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      585
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Sudden death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Infections and infestations - Oth spec
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Stroke
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Acute kidney injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      543
      num Events
      1
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      585
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      543
      num Events
      0
    term
    Thromboembolic event
time Frame
Up to 5 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice