Trial Outcomes & Findings for Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NCT NCT03639948)
NCT ID: NCT03639948
Last Updated: 2024-04-11
Results Overview
Defined as the percentage of patients with PCR, as evidenced by absence of invasive disease in breast and axillary lymph nodes determined by histopathological examination.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Up to 25 weeks
Results posted on
2024-04-11
Participant Flow
5 patients were found to be ineligible after enrollment and are not included in assessment for study outcomes.
Participant milestones
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembrolizumab
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=115 Participants
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Age, Continuous
|
50 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
115 Participants
n=93 Participants
|
|
Lymph node status
Negative
|
70 Participants
n=93 Participants
|
|
Lymph node status
Positive
|
45 Participants
n=93 Participants
|
|
T stage
T1
|
21 Participants
n=93 Participants
|
|
T stage
T2
|
73 Participants
n=93 Participants
|
|
T stage
T3
|
21 Participants
n=93 Participants
|
|
T stage
T4
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 25 weeksPopulation: Evaluable for pathologic response
Defined as the percentage of patients with PCR, as evidenced by absence of invasive disease in breast and axillary lymph nodes determined by histopathological examination.
Outcome measures
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=111 Participants
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Pathological Complete Response (pCR) Rate
|
64 Participants
|
SECONDARY outcome
Timeframe: Up to 25 weeksPopulation: Residual cancer burden (RCB) class available
Defined as the percentage of patients with MRD, as evidenced by residual cancer burden (RCB) score of 0/1. Residual cancer burden score for each patient is calculated using surgical pathology parameters using an online tool (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3).
Outcome measures
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=110 Participants
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Minimal Residual Disease (MRD) Rate
|
76 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intention-to-treat
Percentage of patients with EFS as assessed by Kaplan-Meier method. EFS is defined as time from diagnosis to first invasive locoregional or distant recurrence, study treatment-related death, or breast cancer-related death
Outcome measures
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=115 Participants
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Percentage of Participants With Event-free Survival (EFS) as Assessed by Kaplan-Meier Method
|
86 Survival percentage by Kaplan-Meier
Interval 77.0 to 95.0
|
Adverse Events
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
Serious events: 17 serious events
Other events: 115 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=115 participants at risk
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
2.6%
3/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Fatigue
|
1.7%
2/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
2/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Infections and infestations
Osteomyelitis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Infections and infestations
Cellulitis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Infections and infestations
Encephalitis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Fever
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Flu-like symptoms
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Infections and infestations
Bacteremia
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Investigations
Creatinine increased
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Enteritis
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
1/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
Other adverse events
| Measure |
Experimental: Carboplatin & Docetaxel Plus Pembroluzimab
n=115 participants at risk
Carboplatin (Area under the curve \[AUC\] 6 intravenously \[IV\]) and Docetaxel (75 milligrams per meter squared \[mg/m2\], IV) plus Pembrolizumab (200 milligrams \[mg\], IV) every 21 days for 6 cycles.
Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Carboplatin: Intravenous solution
Docetaxel: Intravenous solution
Pembrolizumab: Intravenous solution
Pegfilgrastim: Injectable product
|
|---|---|
|
General disorders
Fatigue
|
75.7%
87/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Diarrhea
|
62.6%
72/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Nausea
|
59.1%
68/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.9%
47/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Constipation
|
38.3%
44/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Nervous system disorders
Dysgeusia
|
35.7%
41/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.9%
39/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.9%
39/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.8%
32/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.3%
28/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Eye disorders
Watering eyes
|
23.5%
27/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
26/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Edema limbs
|
22.6%
26/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.9%
24/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Blood and lymphatic system disorders
Anemia
|
18.3%
21/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.4%
20/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
17.4%
20/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Psychiatric disorders
Insomnia
|
16.5%
19/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Nervous system disorders
Headache
|
13.9%
16/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Vascular disorders
Hot flashes
|
13.0%
15/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
6/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.3%
13/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Fever
|
11.3%
13/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Investigations
Hypomagnesemia
|
11.3%
13/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
12/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
12/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.7%
10/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Investigations
Hypokalemia
|
8.7%
10/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
General disorders
Dizziness
|
7.8%
9/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.8%
9/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.8%
9/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Investigations
Creatinine increased
|
5.2%
6/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
|
|
Investigations
Platelet count decreased
|
5.2%
6/115 • 20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
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Additional Information
Dr. Priyanka Sharma
University of Kansas Medical Center
Phone: 913-588-6029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place