Trial Outcomes & Findings for Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction (NCT NCT01208974)
NCT ID: NCT01208974
Last Updated: 2025-06-26
Results Overview
The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Up to 13 weeks
Results posted on
2025-06-26
Participant Flow
Participants undergo NAC-Sparing Mastectomy, and then receive prophylactic radiation therapy according to a dose-escalation/de-escalation design, the first cohort of 2 to 6 patients starting at dose level II (10 Fractions of 2.5 Gy). If 2 or more participants experience dose-limiting toxicities at the starting dose level (dose level II), then de-escalation occurs to dose level I (10 Fractions of 2.0 Gy) for the next cohort of 2 to 6 participants. No participants were assigned to dose level I.
Participant milestones
| Measure |
NAC-Sparing Mastectomy
Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4. All participants complete this surgery and post-mastectomy period before being assigned to a dosing arm for prophylactic radiation therapy.
|
Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy (Starting Dose)
The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
|
Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy
The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
|
Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy
The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
|
|---|---|---|---|---|
|
NAC-Sparing Mastectomy
STARTED
|
21
|
0
|
0
|
0
|
|
NAC-Sparing Mastectomy
COMPLETED
|
21
|
0
|
0
|
0
|
|
NAC-Sparing Mastectomy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Post-Mastectomy Period (Weeks 1 to 4)
STARTED
|
21
|
0
|
0
|
0
|
|
Post-Mastectomy Period (Weeks 1 to 4)
COMPLETED
|
18
|
0
|
0
|
0
|
|
Post-Mastectomy Period (Weeks 1 to 4)
NOT COMPLETED
|
3
|
0
|
0
|
0
|
|
Prophylactic NAC RT (Weeks 5 to 8)
STARTED
|
0
|
6
|
6
|
6
|
|
Prophylactic NAC RT (Weeks 5 to 8)
Cohort 1: Starting Dose
|
0
|
6
|
0
|
0
|
|
Prophylactic NAC RT (Weeks 5 to 8)
Cohort 2: 1st Dose Escalation
|
0
|
0
|
6
|
0
|
|
Prophylactic NAC RT (Weeks 5 to 8)
Cohort 3: 2nd Dose Escalation
|
0
|
0
|
0
|
6
|
|
Prophylactic NAC RT (Weeks 5 to 8)
COMPLETED
|
0
|
6
|
6
|
6
|
|
Prophylactic NAC RT (Weeks 5 to 8)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NAC-Sparing Mastectomy
Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4. All participants complete this surgery and post-mastectomy period before being assigned to a dosing arm for prophylactic radiation therapy.
|
Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy (Starting Dose)
The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
|
Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy
The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
|
Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy
The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
|
|---|---|---|---|---|
|
Post-Mastectomy Period (Weeks 1 to 4)
Physician Decision
|
1
|
0
|
0
|
0
|
|
Post-Mastectomy Period (Weeks 1 to 4)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Post-Mastectomy Period (Weeks 1 to 4)
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
Baseline characteristics by cohort
| Measure |
Phase 1 MTD NAC RT
n=21 Participants
Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:
* Dose Level I - 10 fractions of 2.0 Gy for a total of 20 Gy
* Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy
* Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy
* Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy
Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT).
Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 13 weeksPopulation: A total of 18 participants at dose-escalating study design (6 participants at each dose level - Levels II, III and IV) who received prophylactic NAC RT after nipple-sparing mastectomy were evaluated to assess the MTD/Recommended Phase II dose.
The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Outcome measures
| Measure |
Prophylactic NAC RT After Nipple-Sparing Mastectomy
n=18 Participants
Participants who received NAC RT after nipple-sparing mastectomy at the following dose levels:
* Dose Level II: 6 participants receiving 10 fractions at 2.5 grays (gy) for total of 25 Gy.
* Dose Level III: 6 participants receiving 10 fractions at 3.0 grays (gy) for total of 30 Gy.
* Dose Level IV: 6 participants receiving 10 fractions at 3.5 grays (gy) for total of 35 Gy.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
|
35 Gy (grays)
|
SECONDARY outcome
Timeframe: 12 monthsCosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsDisease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact..
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsRate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof.
Outcome measures
Outcome data not reported
Adverse Events
NAC-Sparing Mastectomy
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NAC-Sparing Mastectomy
n=21 participants at risk
Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4.
|
Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy
n=6 participants at risk
The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
|
Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy
n=6 participants at risk
The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
|
Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy
n=6 participants at risk
The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Surgery/Intra-Operative Injury
|
4.8%
1/21 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Pain - Other
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
4.8%
1/21 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
Other adverse events
| Measure |
NAC-Sparing Mastectomy
n=21 participants at risk
Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4.
|
Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy
n=6 participants at risk
The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy.
|
Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy
n=6 participants at risk
The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II.
|
Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy
n=6 participants at risk
The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Back Pain
|
9.5%
2/21 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Breast Pain
|
42.9%
9/21 • Number of events 10 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Chest Wall Pain
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Nervous system disorders
Depression
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis: Radiation
|
0.00%
0/21 • Up to 8 months
|
66.7%
4/6 • Number of events 4 • Up to 8 months
|
66.7%
4/6 • Number of events 4 • Up to 8 months
|
100.0%
6/6 • Number of events 8 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Small area of scab on the left nipple
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Skin sloughing
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Nipple congestion
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Nipple eschar
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Occasional tightness in the axillary redion
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Crusting on incisions
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Burning sensation along the incisions
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Right nipple with slight bulla
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Skin necrosis (on the side of right prophylactic reconstructed breast)
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Left breast skin necrosis cancer side
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Fatigue
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Headache
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Hematoma
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
83.3%
5/6 • Number of events 5 • Up to 8 months
|
83.3%
5/6 • Number of events 5 • Up to 8 months
|
50.0%
3/6 • Number of events 3 • Up to 8 months
|
|
General disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Myalgia
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
28.6%
6/21 • Number of events 6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Reproductive system and breast disorders
Breast nipple/areolar deformity
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Pain
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Occasional pain in the axillary region
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Pain in extremity
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Pain of skin
|
0.00%
0/21 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/21 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
4.8%
1/21 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/21 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Immune system disorders
Vasculitis
|
0.00%
0/21 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
9.5%
2/21 • Number of events 2 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
9.5%
2/21 • Number of events 2 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place