NCT02595879 · ADVERSE EVENTS

Adverse events

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer · Source last updated 2026-07-31

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

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

Collection time frame: Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Other-event reporting threshold: 0%

Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Triapine (100mg) + Chemoradiation) Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO	8 / 17	17 / 17	0 / 17
Triapine (150mg) + Chemoradiation) Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.	2 / 4	4 / 4	0 / 4

Group identifiers: EG000: Triapine (100mg) + Chemoradiation) · EG001: Triapine (150mg) + Chemoradiation)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Decreased platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Vascular access complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Methemoglobinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Compartment syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Stroke
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Acute kidney injury

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Blood bicarbonate decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
4
term
Decreased platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Luekocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
4
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
4
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Flashing lights
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal distension

Complete source fields

description

Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).

event Groups

deaths Num Affected
0
deaths Num At Risk
17
description
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
8
serious Num At Risk
17
title
Triapine (100mg) + Chemoradiation)
deaths Num Affected
0
deaths Num At Risk
4
description
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Triapine (150mg) + Chemoradiation)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Blood bicarbonate decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
13
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
4
term
Decreased platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Luekocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
4
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
4
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Flashing lights
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Decreased platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Vascular access complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
4
term
Methemoglobinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Compartment syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Stroke
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
4
term
Acute kidney injury

time Frame

Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality

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Preserved source evidence · Not medical advice