Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
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.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.
What was measured
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Analysis population: Participants who received any study treatment
Groups in this outcome
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
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
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
208
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
202
Reported measurements
Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
23
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
18
Not reported
Not reported
Not reported
Not reported
Other blood and lymphatic system disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
5
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
7
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
19
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
17
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
5
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
2
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
13
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
4
Not reported
Not reported
Not reported
Not reported
Other investigations
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
39
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
41
Not reported
Not reported
Not reported
Not reported
Cardiac disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
2
Not reported
Not reported
Not reported
Not reported
Eye disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
1
Not reported
Not reported
Not reported
Not reported
Gastrointestinal disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
22
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
22
Not reported
Not reported
Not reported
Not reported
General disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
7
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
1
Not reported
Not reported
Not reported
Not reported
Hepatobiliary disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
0
Not reported
Not reported
Not reported
Not reported
Infections and infestations
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
17
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
12
Not reported
Not reported
Not reported
Not reported
Metabolism and nutrition disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
29
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
22
Not reported
Not reported
Not reported
Not reported
Musculoskeletal and connective tissue disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
3
Not reported
Not reported
Not reported
Not reported
Neoplasms benign, malignant and unspecified
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
1
Not reported
Not reported
Not reported
Not reported
Nervous system disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
5
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
4
Not reported
Not reported
Not reported
Not reported
Psychiatric disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
1
Not reported
Not reported
Not reported
Not reported
Renal and urinary disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
4
Not reported
Not reported
Not reported
Not reported
Reproductive system and breast disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
8
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
11
Not reported
Not reported
Not reported
Not reported
Respiratory, thoracic and mediastinal disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
1
Not reported
Not reported
Not reported
Not reported
Skin and subcutaneous tissue disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
0
Not reported
Not reported
Not reported
Not reported
Surgical and medical procedures
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
0
Not reported
Not reported
Not reported
Not reported
Vascular disorders
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
20
Not reported
Not reported
Not reported
Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
11
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
18
title
Anemia
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
title
Other blood and lymphatic system disorders
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
17
title
White blood cell count decreased
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
title
Platelet count decreased
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
4
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
41
title
Other investigations
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Cardiac disorders
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Eye disorders
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
22
title
Gastrointestinal disorders
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
1
title
General disorders
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Hepatobiliary disorders
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
12
title
Infections and infestations
denoms
counts
group Id
OG000
value
208
group Id
OG001
value
202
units
Participants
description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
groups
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
OG000
title
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
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
OG001
title
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who received any study treatment
reporting Status
POSTED
time Frame
During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.
title
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Triangle