Trial Outcomes & Findings for Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer (NCT NCT03018080)

Last Updated: 2023-08-04

Results Overview

Grade 3 or 4 study treatment-related adverse events will be determined for each subject as a binary variable indicating whether or not the subject experienced at least one grade 3 or 4 study treatment-related adverse events according to the NCI Common Terminology for Adverse Events, version 4.0. An adverse event will be considered study treatment related if it is determined that the event is at least possibly related to either paclitaxel, pembrolizumab, or both.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

From enrollment to at least 30 days following cessation of study treatment. The median time on treatment was 5.5 months.

Results posted on

2023-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Phased Pembrolizumab Regimen) Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Overall Study STARTED	21	19
Overall Study COMPLETED	9	0
Overall Study NOT COMPLETED	12	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Phased Pembrolizumab Regimen) Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Overall Study Death	12	19

Baseline Characteristics

Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Total n=40 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	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants	57 years n=7 Participants	56.5 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 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	1 Participants n=5 Participants	0 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
ECOG at Baseline 0	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
ECOG at Baseline 1	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
ECOG at Baseline 2	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Hormone Receptor Status HR Positive	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Hormone Receptor Status HR Negative	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Prior Paclitaxel Exposure Prior Paclitaxel	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Prior Paclitaxel Exposure No Prior Paclitaxel	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Prior Paclitaxel Exposure Unknown	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Prior Docetaxel Exposure Prior Docetaxel	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Prior Docetaxel Exposure No Prior Docetaxel	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Prior Docetaxel Exposure Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Number of Prior Metastatic Chemotherapy Lines 0	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Number of Prior Metastatic Chemotherapy Lines 1	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Number of Prior Metastatic Chemotherapy Lines 2	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Number of Prior Metastatic Chemotherapy Lines 3	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to at least 30 days following cessation of study treatment. The median time on treatment was 5.5 months.

Population: The evaluable population will consist of all randomized subjects who begin study therapy.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Number of Participants With at Least One Grade 3 or 4 Treatment-related Adverse Event	5 Participants	6 Participants

SECONDARY outcome

Timeframe: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for a median of 5.5 months)

Population: The evaluable population will consist of all randomized subjects who begin study therapy and have measurable disease at baseline.

Objective response was determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 response criteria. A CR is indicated by disappearance of all target and non target lesions. A PR is indicated by \>=30% decrease in sum of longest diameter of target lesions with baseline as reference.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Number of Subjects With an Objective Response (Per RECIST V1.1)	4 Participants	8 Participants

SECONDARY outcome

Timeframe: From treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.

Population: The evaluable population for PFS consisted of all randomized subjects who begin study therapy

PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per RECIST 1.1 criteria, where progression date is date of last assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Progression-free Survival (PFS) Per RECIST 1.1	4.1 Months Interval 1.4 to 6.9	3.9 Months Interval 1.4 to 6.8

SECONDARY outcome

Timeframe: From date of treatment start to date of death, or censored as described; assessed for approximately 5 years.

Population: The evaluable population consisted of all randomized subjects who begin study therapy.

OS is defined as the duration from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow up at the time of the analysis will be censored at the last known date they were alive.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Overall Survival (OS)	27.6 Months Interval 9.7 to Upper limit of the confidence interval is not reached due to censoring rate	9.0 Months Interval 6.8 to 14.0

SECONDARY outcome

Population: The evaluable population will consist of all randomized subjects who begin study therapy and have measurable disease at baseline.

Disease control was determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by RECIST 1.1 response criteria. A CR is indicated by disappearance of all target and non target lesions. A PR is indicated by \>=30% decrease in sum of longest diameter of target lesions with baseline as reference. SD is indicated by neither sufficient shrinkage to qualify for PR nor sufficient growth from nadir (\>=20%) to indicate progression.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=21 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Number of Subjects With Disease Control (Per RECIST V1.1)	14 Participants	12 Participants

SECONDARY outcome

Timeframe: From date of response to date of progression/death, or censored as described above; assessed for approximately 2 years.

Population: The evaluable population consisted of all randomized subjects who begin study therapy and achieve objective response (CR or PR) on study treatment.

Duration of Response (DoR) is defined as the duration of time from the first assessment that determined a CR or PR to the date of the first occurrence of progressive disease or death. Progression events and the censoring mechanism for DoR will be the same as described for PFS. DoR will be determined for each subject using the RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Arm A (Phased Pembrolizumab Regimen) n=4 Participants Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=8 Participants Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Duration of Response (DoR)	7.3 Months Interval 5.6 to 8.3	4.0 Months Interval 2.6 to 8.3

Adverse Events

Arm A (Phased Pembrolizumab Regimen)

Serious events: 4 serious events

Other events: 21 other events

Deaths: 12 deaths

Arm B (Concurrent Pembrolizumab Regimen)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Additional Information

Chair of Biostatistics Department

Levine Cancer Institute

Phone: 9804422371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (Phased Pembrolizumab Regimen) n=21 participants at risk Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle	Arm B (Concurrent Pembrolizumab Regimen) n=19 participants at risk Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days. Pembrolizumab: IV (in the vein) on day 1 of a 21 day cycle Paclitaxel: IV (in the vein) on days 1 and 8 of a 21 day cycle
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Gastrointestinal disorders Diarrhea	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
General disorders Death NOS	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	10.5% 2/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
General disorders Fever	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Hepatobiliary disorders Hepatic failure	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Infections and infestations Skin infection	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	10.5% 2/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Infections and infestations Urinary tract infection	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Infections and infestations Enterocolitis infectious	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Infections and infestations Lung infection	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Metabolism and nutrition disorders Hypoglycemia	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Renal and urinary disorders Cystitis noninfective	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Renal and urinary disorders Acute kidney injury	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 1/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	0.00% 0/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/21 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.	5.3% 1/19 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.