Trial Outcomes & Findings for CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma (NCT NCT03542266)
NCT ID: NCT03542266
Last Updated: 2023-08-22
Results Overview
Complete response rate (CR) of CC486-CHOP in PTCL by Lugano Criteria for target lesions, and the Deauville Criteria (5 point scale) assessed by PET or CT; CR (complete metabolic or radiologic response) defined as Deauville score of 1, 2 or 3 by PET or regression of all target lesions to \< 1.5cm in longest diameter by CT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
After Cycle 6 at 18 weeks
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
CC486 +CHOP
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Treatment Phase
STARTED
|
21
|
|
Treatment Phase
COMPLETED
|
18
|
|
Treatment Phase
NOT COMPLETED
|
3
|
|
Post-treatment Follow-up Phase
STARTED
|
15
|
|
Post-treatment Follow-up Phase
COMPLETED
|
0
|
|
Post-treatment Follow-up Phase
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
CC486 +CHOP
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Treatment Phase
Withdrawal by Subject
|
1
|
|
Treatment Phase
Adverse Event
|
1
|
|
Treatment Phase
PD
|
1
|
Baseline Characteristics
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
CC486 +CHOP
n=21 Participants
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After Cycle 6 at 18 weeksPopulation: 3 of 21 participants did not complete treatment as outlined in the Participant Flow section; these subject were unevaluable and not included in analysis.
Complete response rate (CR) of CC486-CHOP in PTCL by Lugano Criteria for target lesions, and the Deauville Criteria (5 point scale) assessed by PET or CT; CR (complete metabolic or radiologic response) defined as Deauville score of 1, 2 or 3 by PET or regression of all target lesions to \< 1.5cm in longest diameter by CT.
Outcome measures
| Measure |
CC486 +CHOP
n=18 Participants
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Complete Response Rate
|
75 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 1 patient had missing overall survival information.
Overall Survival (OS) assessed by Kaplan-Meier survival analysis. The Kaplan-Meier overall survival estimate at 2 years (with 95% confidence interval) is reported. OS defined as the time from first treatment day until death (or until last follow-up if alive).
Outcome measures
| Measure |
CC486 +CHOP
n=20 Participants
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Kaplan-Meier Overall Survival
|
68.0 percentage of participants
Interval 46.7 to 89.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 1 participant had missing progression-free survival information.
Progression-free survival (PFS) assessed by Kaplan-Meier survival analysis. The Kaplan-Meier progression-free survival estimate at 2 years (with 95% confidence interval) is reported. PFS defined as the time from first treatment day until objective or symptomatic progression or death (or date of last follow-up if no progression/death).
Outcome measures
| Measure |
CC486 +CHOP
n=20 Participants
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Kaplan-Meier Progression-Free Survival
|
65.8 percentage of participants
Interval 43.4 to 88.1
|
Adverse Events
CC486 +CHOP
Serious events: 6 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CC486 +CHOP
n=21 participants at risk
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Neutopenic Fever
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Blood Bilirubin Increase
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Influenza A
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Lung Infection, COVID-19
|
4.8%
1/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
Other adverse events
| Measure |
CC486 +CHOP
n=21 participants at risk
CC486 +CHOP
CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
10/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Cardiac disorders
Orthostatic hypotension
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
7/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Constipation
|
90.5%
19/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
11/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Mucositis Oral
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
15/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Stomach Pain
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
47.6%
10/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Edema limbs
|
28.6%
6/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Fatigue
|
66.7%
14/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Fever
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Generalized weakness
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Non-cardiac chest pain
|
19.0%
4/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Night sweats
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
General disorders
Weight loss
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Oral Candidiasis
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Rhinovirus
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Skin infection
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Alkaline phosphatase increased
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Lymphocyte count decreased
|
61.9%
13/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Neutrophil count decreased
|
71.4%
15/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Transaminitis
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
Platelet count decreased
|
52.4%
11/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Investigations
White blood cell decreased
|
57.1%
12/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
6/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Dizziness
|
28.6%
6/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Headache
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Neuropathy
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Nervous system disorders
Syncope
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Psychiatric disorders
Anxiety
|
19.0%
4/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.8%
5/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
4/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
3/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Vascular disorders
Hypertension
|
19.0%
4/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
|
Vascular disorders
Superficial thrombophlebitis
|
9.5%
2/21 • From time of informed consent to 28 days post last dose of study drug, approximately 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place