Trial Outcomes & Findings for Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (NCT NCT01627288)
NCT ID: NCT01627288
Last Updated: 2021-02-08
Results Overview
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
During RT to 6 weeks post RT
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
Boost Radiation: Dose Level 1
2.4 Gy X 25 fractions = 60 Gy
|
Boost Radiation: Dose Level 2
2.6 Gy X 25 fractions = 65 Gy
|
Boost Radiation: Dose Level 3
2.8 Gy x 25 fractions = 70 Gy
|
Boost Radiation Dose Level 0
If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.
Dose level 0: 2.2 Gy X 25 fractions = 55 Gy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Baseline characteristics by cohort
| Measure |
Boost Radiation: Dose Level 1
n=3 Participants
2.4 Gy X 25 fractions = 60 Gy
|
Boost Radiation: Dose Level 2
n=3 Participants
2.6 Gy X 25 fractions = 65 Gy
|
Boost Radiation: Dose Level 3
n=6 Participants
2.8 Gy x 25 fractions = 70 Gy
|
Boost Radiation Dose Level 0
If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.
Dose level 0: 2.2 Gy X 25 fractions = 55 Gy
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
—
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During RT to 6 weeks post RTConcurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
|
70 Gray (Gy)
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 years following treatmentLocal-regional control is defined as local control without any nodal recurrence.
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
|
1.5 years
Standard Deviation 0.1
|
NA years
Standard Deviation NA
the value could not be calculated due to no events
|
0.65 years
Standard Deviation NA
the value could not be calculated due to too few events
|
1.52 years
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 3 years after treatmentOutcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Time to Distant Recurrence (TTDR)
|
1.4 years
Standard Deviation 0.1
|
NA years
Standard Deviation NA
the value could not be calculated due to no events
|
1.2 years
Standard Deviation NA
the value could not be calculated due to too few events
|
1.29 years
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 3 years after treatmentOutcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Disease Free Survival (DFS)
|
1.3 years
Standard Deviation 0.1
|
0.85 years
Standard Deviation NA
the value could not be calculated due to too few events
|
1.05 years
Standard Deviation 0.23
|
1.34 years
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 3 years after treatmentOutcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
1.6 years
Standard Deviation 0.1
|
0.85 years
Standard Deviation NA
the value could not be calculated due to too few events
|
1.08 years
Standard Deviation NA
the value could not be calculated due to too few events
|
1.7 years
Standard Deviation NA
the value could not be calculated due to too few events
|
SECONDARY outcome
Timeframe: 6 weeks following treatmentAcute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Number of Participants With Acute Dose Limiting Toxicities (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 years following treatmentLate DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
Outcome measures
| Measure |
Treatment Arm
n=12 Participants
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3), 2.6 Gy X 25 fractions = 65 Gy (N=6), or 2.8 Gy x 25 fractions = 70 Gy (N=12).
|
Boost Radiation: Dose Level 1 (60 Gy)
n=3 Participants
Dose level 1 consists of a total 60Gy given in 2.4 Gy per fraction
|
Boost Radiation: Dose Level 2 (65)
n=3 Participants
Dose level 2 consists of a total 65Gy given in 2.6 Gy per fraction
|
Boost Radiation: Dose Level 3 (70Gy)
n=6 Participants
Dose level 3 consists of a total 70Gy given in 2.8 Gy per fraction
|
|---|---|---|---|---|
|
Number of Participants With Late Dose Limiting Toxicities (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3)
|
Dose Level 2
n=3 participants at risk
2.6 Gy X 25 fractions = 65 Gy (N=3),
|
Dose Level 3
n=6 participants at risk
2.8 Gy x 25 fractions = 70 Gy (N=6)
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Rectal necrosis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Urinary fistula
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3)
|
Dose Level 2
n=3 participants at risk
2.6 Gy X 25 fractions = 65 Gy (N=3),
|
Dose Level 3
n=6 participants at risk
2.8 Gy x 25 fractions = 70 Gy (N=6)
|
|---|---|---|---|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
50.0%
3/6 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • 3 years
|
100.0%
6/6 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoiids
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • 3 years
|
66.7%
2/3 • 3 years
|
83.3%
5/6 • 3 years
|
|
Gastrointestinal disorders
Proctitis
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
50.0%
3/6 • 3 years
|
|
General disorders
Edema limbs
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • 3 years
|
33.3%
1/3 • 3 years
|
66.7%
4/6 • 3 years
|
|
General disorders
Pain
|
66.7%
2/3 • 3 years
|
66.7%
2/3 • 3 years
|
66.7%
4/6 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Infections and infestations
ry tract infection
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Investigations
Weight loss
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • 3 years
|
66.7%
2/3 • 3 years
|
50.0%
3/6 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
66.7%
2/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
66.7%
4/6 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Reproductive system and breast disorders
Vaginismus
|
33.3%
1/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • 3 years
|
0.00%
0/6 • 3 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • 3 years
|
Additional Information
Jennifer Mewshaw, MS RN
Duke University Health System
Phone: (919) 668-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place