Trial Outcomes & Findings for A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer (NCT NCT04499521)
NCT ID: NCT04499521
Last Updated: 2025-03-17
Results Overview
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy
Results posted on
2025-03-17
Participant Flow
Participants were recruited based on physician referral at one academic medical center between March 2021 and September 2022. Participants were randomized with equal allocation to each ordering (Arm A or Arm B) using a stratified block randomization scheme with varying block sizes (of 2-4). Randomization occurred prior to the 2nd fraction of brachytherapy.
Fraction 1 for all participants (both Arms) was performed with standard of care packing. One patient of the 21 patients enrolled and randomized did not receive brachytherapy due to disease progression.
Participant milestones
| Measure |
Arm A: BrachyGel in Fractions 3 and 5
BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
Arm B: BrachyGel in Fractions 2 and 4
BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A: BrachyGel in Fractions 3 and 5
BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
Arm B: BrachyGel in Fractions 2 and 4
BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Baseline characteristics by cohort
| Measure |
Arm A: BrachyGel in Fractions 3 and 5
n=10 Participants
BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
Arm B: BrachyGel in Fractions 2 and 4
n=10 Participants
BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
52.9 years
n=5 Participants
|
51 years
n=7 Participants
|
51.95 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapyPopulation: 19 participants were evaluated. A major protocol deviation that occurred for one ARM B subject during fraction (Fx) 2 of brachytherapy (use of an incorrect packing method). This subject is not included in the analysis of this endpoint.
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3
Outcome measures
| Measure |
ARM A Fraction 2
n=10 Participants
Gauze
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM A Fraction 3
n=10 Participants
BrachyGel
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM B Fraction 2
n=9 Participants
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
n=10 Participants
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 2
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 4
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 5
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
|---|---|---|---|---|---|---|---|---|
|
Dosimetry Comparison of Packing System in OARs
Bladder D2cc
|
3.436 Mean in Dose (Gray)
Standard Deviation 0.684
|
3.319 Mean in Dose (Gray)
Standard Deviation 0.586
|
3.636 Mean in Dose (Gray)
Standard Deviation 0.772
|
3.573 Mean in Dose (Gray)
Standard Deviation 0.791
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D2cc
|
3.071 Mean in Dose (Gray)
Standard Deviation 0.386
|
3.26 Mean in Dose (Gray)
Standard Deviation 0.357
|
3.211 Mean in Dose (Gray)
Standard Deviation 0.693
|
3.03 Mean in Dose (Gray)
Standard Deviation 0.722
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
Bladder D0.1cc
|
4.457 Mean in Dose (Gray)
Standard Deviation 1.035
|
4.311 Mean in Dose (Gray)
Standard Deviation 0.78
|
4.911 Mean in Dose (Gray)
Standard Deviation 1.018
|
4.705 Mean in Dose (Gray)
Standard Deviation 0.916
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
Bladder D1cc
|
3.745 Mean in Dose (Gray)
Standard Deviation 0.774
|
3.601 Mean in Dose (Gray)
Standard Deviation 0.586
|
4.026 Mean in Dose (Gray)
Standard Deviation 0.845
|
3.908 Mean in Dose (Gray)
Standard Deviation 0.828
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D1cc
|
3.417 Mean in Dose (Gray)
Standard Deviation 0.492
|
3.591 Mean in Dose (Gray)
Standard Deviation 0.405
|
3.51 Mean in Dose (Gray)
Standard Deviation 0.789
|
3.316 Mean in Dose (Gray)
Standard Deviation 0.812
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D0.1cc
|
4.117 Mean in Dose (Gray)
Standard Deviation 0.713
|
4.34 Mean in Dose (Gray)
Standard Deviation 0.681
|
4.381 Mean in Dose (Gray)
Standard Deviation 1.06
|
4.028 Mean in Dose (Gray)
Standard Deviation 1.134
|
—
|
—
|
—
|
—
|
|
Dosimetry Comparison of Packing System in OARs
HR-CTVD90
|
6.518 Mean in Dose (Gray)
Standard Deviation 1.313
|
6.638 Mean in Dose (Gray)
Standard Deviation 0.901
|
5.917 Mean in Dose (Gray)
Standard Deviation 0.893
|
6.575 Mean in Dose (Gray)
Standard Deviation 0.869
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)Population: All participants who received at least Brachytherapy Fraction 2
Frequency and intensity (CTCAE v5 grade) of AEs
Outcome measures
| Measure |
ARM A Fraction 2
n=20 Participants
Gauze
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM A Fraction 3
n=20 Participants
BrachyGel
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM B Fraction 2
n=20 Participants
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 2
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 4
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 5
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events
Vaginal dryness (itching) Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal inflammation Grade 1
|
0 Occurences
|
1 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal inflammation Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Dysuria Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Dysuria Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Pelvic pain (abdominal cramping) Grade 2
|
0 Occurences
|
0 Occurences
|
2 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Pelvic pain (abdominal cramping) Grade 1
|
0 Occurences
|
0 Occurences
|
3 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Bloating Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Bone Pain Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Facial Pain Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
UTI Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Infection (Scabies)* Grade 3
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal pain Grade 2
|
2 Occurences
|
0 Occurences
|
2 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal pain Grade 1
|
0 Occurences
|
0 Occurences
|
3 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal hemorrhage (Spotting) Grade 1
|
1 Occurences
|
1 Occurences
|
2 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Urinary urgency Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Pelvic Pain Grade 3
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Fatigue Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Fatigue Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Diarrhea Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Constipation Grade 1
|
0 Occurences
|
0 Occurences
|
2 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Dyspareunia Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Dermatitis Radiation Grade 2
|
0 Occurences
|
0 Occurences
|
2 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Dizziness Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Nausea Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vomiting Grade 2
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Cough Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events
Vaginal Infection Grade 1
|
0 Occurences
|
0 Occurences
|
1 Occurences
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapyPopulation: A major protocol deviation that occurred for one ARM B subject during fraction (Fx) 2 of brachytherapy (use of an incorrect packing method). Two subjects one from ARM A and one from ARM B only received 4 fractions of treatment. These subjects are not included in the analysis of this endpoint.
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5.
Outcome measures
| Measure |
ARM A Fraction 2
n=10 Participants
Gauze
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM A Fraction 3
n=10 Participants
BrachyGel
ARM A: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
|
ARM B Fraction 2
n=10 Participants
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
n=9 Participants
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 2
n=9 Participants
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 3
n=10 Participants
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 4
n=10 Participants
BrachyGel
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
ARM B Fraction 5
n=9 Participants
Gauze
ARM B: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
|
|---|---|---|---|---|---|---|---|---|
|
Dosimetry Comparison of Packing System in OARs
Bladder D1cc
|
3.745 Mean in dose (Gray)
Standard Deviation 0.774
|
3.601 Mean in dose (Gray)
Standard Deviation 0.586
|
3.611 Mean in dose (Gray)
Standard Deviation 1.142
|
4.166 Mean in dose (Gray)
Standard Deviation 0.873
|
4.026 Mean in dose (Gray)
Standard Deviation 0.845
|
3.908 Mean in dose (Gray)
Standard Deviation 0.828
|
3.453 Mean in dose (Gray)
Standard Deviation 1.234
|
4.072 Mean in dose (Gray)
Standard Deviation 0.977
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D1cc
|
3.417 Mean in dose (Gray)
Standard Deviation 0.492
|
3.591 Mean in dose (Gray)
Standard Deviation 0.405
|
3.378 Mean in dose (Gray)
Standard Deviation 0.664
|
3.201 Mean in dose (Gray)
Standard Deviation 0.919
|
3.51 Mean in dose (Gray)
Standard Deviation 0.789
|
3.316 Mean in dose (Gray)
Standard Deviation 0.812
|
3.015 Mean in dose (Gray)
Standard Deviation 0.725
|
3.236 Mean in dose (Gray)
Standard Deviation 0.73
|
|
Dosimetry Comparison of Packing System in OARs
Bladder D0.1cc
|
4.457 Mean in dose (Gray)
Standard Deviation 1.035
|
4.311 Mean in dose (Gray)
Standard Deviation 0.78
|
4.322 Mean in dose (Gray)
Standard Deviation 1.352
|
4.974 Mean in dose (Gray)
Standard Deviation 1.144
|
4.911 Mean in dose (Gray)
Standard Deviation 1.018
|
4.705 Mean in dose (Gray)
Standard Deviation 0.916
|
4.287 Mean in dose (Gray)
Standard Deviation 1.518
|
5.031 Mean in dose (Gray)
Standard Deviation 1.186
|
|
Dosimetry Comparison of Packing System in OARs
HR-CTVD90
|
6.518 Mean in dose (Gray)
Standard Deviation 1.313
|
6.638 Mean in dose (Gray)
Standard Deviation 0.901
|
6.749 Mean in dose (Gray)
Standard Deviation 1.501
|
6.692 Mean in dose (Gray)
Standard Deviation 0.522
|
5.917 Mean in dose (Gray)
Standard Deviation 0.893
|
6.575 Mean in dose (Gray)
Standard Deviation 0.869
|
6.807 Mean in dose (Gray)
Standard Deviation 1.262
|
6.284 Mean in dose (Gray)
Standard Deviation 0.543
|
|
Dosimetry Comparison of Packing System in OARs
Bladder D2cc
|
3.436 Mean in dose (Gray)
Standard Deviation 0.684
|
3.319 Mean in dose (Gray)
Standard Deviation 0.586
|
3.287 Mean in dose (Gray)
Standard Deviation 1.058
|
3.798 Mean in dose (Gray)
Standard Deviation 0.771
|
3.636 Mean in dose (Gray)
Standard Deviation 0.772
|
3.573 Mean in dose (Gray)
Standard Deviation 0.791
|
3.157 Mean in dose (Gray)
Standard Deviation 1.174
|
3.649 Mean in dose (Gray)
Standard Deviation 0.916
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D2cc
|
3.071 Mean in dose (Gray)
Standard Deviation 0.386
|
3.26 Mean in dose (Gray)
Standard Deviation 0.357
|
3.035 Mean in dose (Gray)
Standard Deviation 0.627
|
2.936 Mean in dose (Gray)
Standard Deviation 0.847
|
3.211 Mean in dose (Gray)
Standard Deviation 0.693
|
3.03 Mean in dose (Gray)
Standard Deviation 0.722
|
2.761 Mean in dose (Gray)
Standard Deviation 0.664
|
2.993 Mean in dose (Gray)
Standard Deviation 0.67
|
|
Dosimetry Comparison of Packing System in OARs
Rectum D0.1cc
|
4.117 Mean in dose (Gray)
Standard Deviation 0.713
|
4.34 Mean in dose (Gray)
Standard Deviation 0.681
|
4.2 Mean in dose (Gray)
Standard Deviation 0.795
|
3.846 Mean in dose (Gray)
Standard Deviation 1.054
|
4.381 Mean in dose (Gray)
Standard Deviation 1.06
|
4.028 Mean in dose (Gray)
Standard Deviation 1.134
|
3.817 Mean in dose (Gray)
Standard Deviation 1.068
|
3.823 Mean in dose (Gray)
Standard Deviation 0.835
|
Adverse Events
BrachyGel for Arm A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gauze for Arm A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Other for Arm A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BrachyGel for Arm B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Gauze for Arm B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Other for Arm B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BrachyGel for Arm A
n=10 participants at risk
Event occurred on or after the day BrachyGel VHPS was used on participants assigned to ARM A
ARM A: Brachygel used during fractions 3 and 5 and standard packing in fractions 2 and 4
|
Gauze for Arm A
n=10 participants at risk
Event occurred on or after the day Gauze was used on participants assigned to ARM A
ARM A: Brachygel used during fractions 3 and 5 and standard packing in fractions 2 and 4
|
Other for Arm A
n=10 participants at risk
Not associated with either packing system due the start date of the event (i.e. started during follow up).
ARM A: Brachygel used during fractions 3 and 5 and standard packing in fractions 2 and 4
|
BrachyGel for Arm B
n=10 participants at risk
Associated with BrachyGel VHPS for participants assigned to ARM B
ARM B: Brachygel used during fractions 2 and 4 and standard packing in fractions 3 and 5
|
Gauze for Arm B
n=10 participants at risk
Event occurred on or after the day Gauze was used on participants assigned to ARM B
ARM B: Brachygel used during fractions 2 and 4 and standard packing in fractions 3 and 5
|
Other for Arm B
n=10 participants at risk
Not associated with either packing system due the start date of the event (i.e. started during follow up).
ARM B: Brachygel used during fractions 2 and 4 and standard packing in fractions 3 and 5
|
|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal Pain
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
20.0%
2/10 • Number of events 2 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
30.0%
3/10 • Number of events 4 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
20.0%
2/10 • Number of events 2 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 2 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
30.0%
3/10 • Number of events 4 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
General disorders
Facial Pain
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Infections and infestations
UTI
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Infections and infestations
Infection (Scabies)
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
10.0%
1/10 • Number of events 1 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
0.00%
0/10 • From completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Adverse events were not collected before the 2nd brachytherapy treatment. The 1st brachytherapy treatment is considered a part of baseline and was performed using gauze per standard of care for all subjects. The time from informed consent to 2nd brachytherapy was up to 14 days and the time from 1st brachytherapy to 2nd brachytherapy was up to 12 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place