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NCT02466971 · ADVERSE EVENTS

Adverse events

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers · Source last updated 2026-08-21

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
All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
Other-event reporting threshold
0%

All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Cisplatin, IMRT or RT, Brachytherapy)

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT

45 / 208198 / 20835 / 224
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)

Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV

45 / 202194 / 20234 / 224

Group identifiers: EG000: Arm I (Cisplatin, IMRT or RT, Brachytherapy) · EG001: Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Blood And Lymphatic System Disorders - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      202
    term
    Anemia
  3. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Chest Pain - Cardiac
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      202
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Upper Gastrointestinal Hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Duodenal Hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Small Intestinal Obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      202
    term
    Abdominal Pain

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Thrombotic Thrombocytopenic Purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Lymph Node Pain
  3. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      202
    term
    Leukocytosis
  4. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Blood And Lymphatic System Disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      202
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Supraventricular Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Sinus Bradycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      202
    term
    Palpitations
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Disorders - Other
Complete source fields
description
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
event Groups
  1. deaths Num Affected
    35
    deaths Num At Risk
    224
    description
    Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
    id
    EG000
    other Num Affected
    198
    other Num At Risk
    208
    serious Num Affected
    45
    serious Num At Risk
    208
    title
    Arm I (Cisplatin, IMRT or RT, Brachytherapy)
  2. deaths Num Affected
    34
    deaths Num At Risk
    224
    description
    Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
    id
    EG001
    other Num Affected
    194
    other Num At Risk
    202
    serious Num Affected
    45
    serious Num At Risk
    202
    title
    Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Thrombotic Thrombocytopenic Purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Lymph Node Pain
  3. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      202
    term
    Leukocytosis
  4. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Blood And Lymphatic System Disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      202
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Supraventricular Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Sinus Bradycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      202
    term
    Palpitations
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Disorders - Other
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Blood And Lymphatic System Disorders - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      202
    term
    Anemia
  3. assessment Type
    NON_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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Chest Pain - Cardiac
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      202
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      202
    term
    Upper Gastrointestinal Hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      202
    term
    Duodenal Hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      202
    term
    Small Intestinal Obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      202
    term
    Abdominal Pain
time Frame
All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.

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