Trial Outcomes & Findings for TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma (NCT NCT02927964)
NCT ID: NCT02927964
Last Updated: 2024-10-16
Results Overview
Dose-limiting toxicity was continuously throughout the trial. Adverse event information was collected at each visit. Safety labs were collected on week 2, 4, 6, 12 and every 12 weeks thereafter until the final study visit.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
Phase I -SD-101 3mg
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Phase II -SD-101 3mg
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1b -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=11 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Phase II -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=10 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Total
n=21 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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 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
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Participants who received treatment are included in the analysis
Dose-limiting toxicity was continuously throughout the trial. Adverse event information was collected at each visit. Safety labs were collected on week 2, 4, 6, 12 and every 12 weeks thereafter until the final study visit.
Outcome measures
| Measure |
Phase 1b -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=6 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Phase II -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|---|
|
Number of Dose-limiting Toxicity Assessed Using Common Terminology Criteria for Adverse Events Version 4.0 (Phase Ib)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Participants who received treatment are included in the analysis
Tumor response rate of intratumoral SD 101 in combination with ibrutinib and radiation in subjects will be assessed. Tumor response rates (complete response, partial response) will be calculated based on the Lugano classification for low-grade B-cell lymphomas.
Outcome measures
| Measure |
Phase 1b -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=11 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Phase II -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=9 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|---|
|
Tumor Response Rates (Phase II)
Partial Response
|
4 Participants
|
5 Participants
|
|
Tumor Response Rates (Phase II)
Complete Response
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Participants who received treatment are included in the analysis
Progression free Survival is defined as the time elapsed between treatment initiation (Day 1) and tumor progression or death from any cause. Progression will be defined using the Lugano Classification. This outcome will be measured on any individual who has received at least one intratumoral injection of SD 101 at the recommended phase 2 dose level.
Outcome measures
| Measure |
Phase 1b -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=11 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
Phase II -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=9 Participants
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|---|
|
Progression-free Survival (Phase II)
|
11 Months
Interval 7.0 to 21.9
|
11 Months
Interval 7.0 to 21.9
|
Adverse Events
Phase 1b/phase2 -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b/phase2 -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=20 participants at risk
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Bacteremia
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Soft tissue infection
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Infection other
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
Other adverse events
| Measure |
Phase 1b/phase2 -SD-101 3mg: Treatment (Radiation Therapy, TLR9 Agonist SD-101, Ibrutinib)
n=20 participants at risk
Patients underwent radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients received TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also received ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.0%
7/20 • Number of events 7 • up to 24 months
|
|
Cardiac disorders
Palpitations
|
30.0%
6/20 • Number of events 7 • up to 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Cardiac disorders
Heart failure
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Eye disorders
Conjunctivitis
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Eye disorders
Eye Pain
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Eye disorders
Dry Eyes
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Eye disorders
Eye Infection
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
16/20 • Number of events 34 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
55.0%
11/20 • Number of events 28 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
45.0%
9/20 • Number of events 14 • up to 24 months
|
|
Gastrointestinal disorders
Oral mucositis
|
35.0%
7/20 • Number of events 14 • up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
8/20 • Number of events 10 • up to 24 months
|
|
Gastrointestinal disorders
Sore Throat
|
20.0%
4/20 • Number of events 13 • up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
4/20 • Number of events 5 • up to 24 months
|
|
Gastrointestinal disorders
Bloating
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Gastrointestinal disorders
Dysgeusia
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Bleeding gum
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Dark stool
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Early satiety
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Epigastric pain
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Swollen lip
|
5.0%
1/20 • Number of events 2 • up to 24 months
|
|
General disorders
Fatigue
|
95.0%
19/20 • Number of events 49 • up to 24 months
|
|
General disorders
Injection site reaction
|
75.0%
15/20 • Number of events 40 • up to 24 months
|
|
General disorders
Chills
|
75.0%
15/20 • Number of events 37 • up to 24 months
|
|
General disorders
Fever
|
55.0%
11/20 • Number of events 22 • up to 24 months
|
|
General disorders
Edema limbs
|
10.0%
2/20 • Number of events 5 • up to 24 months
|
|
General disorders
Malaise
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
General disorders
Chest pain
|
20.0%
4/20 • Number of events 8 • up to 24 months
|
|
General disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
General disorders
General pain
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
General disorders
Naval pain
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
General disorders
Neck pain
|
5.0%
1/20 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
6/20 • Number of events 8 • up to 24 months
|
|
Infections and infestations
Skin infection
|
15.0%
3/20 • Number of events 6 • up to 24 months
|
|
Infections and infestations
Bronchial infection
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Infections and infestations
Bursitis
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Shingles
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Skin wound
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Soft tissue infection
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
60.0%
12/20 • Number of events 15 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
5.0%
1/20 • Number of events 2 • up to 24 months
|
|
Injury, poisoning and procedural complications
Shoulder injury
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Arm injury
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Lymphocyte count decreased
|
45.0%
9/20 • Number of events 18 • up to 24 months
|
|
Investigations
White blood cell count decreased
|
45.0%
9/20 • Number of events 12 • up to 24 months
|
|
Investigations
Neutrophil count decreased
|
30.0%
6/20 • Number of events 11 • up to 24 months
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Investigations
Increased LDH
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Investigations
Alkaline phosphatase decreased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Monocyte increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Neutrophil count increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Lipase increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Lymphocyte count increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Blood bicarbonate decreased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Chloride increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low Chloride
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
High ketones
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low magnesium
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low Phosphorus
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low Ferritin
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low serum globulin concentration
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low transferrin saturation
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
Low Albumin
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Investigations
High PTT
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Platelet count decreased
|
55.0%
11/20 • Number of events 20 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
5/20 • Number of events 7 • up to 24 months
|
|
Metabolism and nutrition disorders
Loss of appetite (anorexia)
|
20.0%
4/20 • Number of events 7 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.0%
3/20 • Number of events 5 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
85.0%
17/20 • Number of events 37 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
10/20 • Number of events 20 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back and shoulder pain
|
35.0%
7/20 • Number of events 17 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping
|
25.0%
5/20 • Number of events 9 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Headache
|
75.0%
15/20 • Number of events 58 • up to 24 months
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Number of events 7 • up to 24 months
|
|
Nervous system disorders
Paresthesia
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Lightheadedness
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 2 • up to 24 months
|
|
Psychiatric disorders
Decreased libido
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
6/20 • Number of events 12 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Number of events 6 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
2/20 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Hemorrhage
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
55.0%
11/20 • Number of events 29 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
5/20 • Number of events 7 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
20.0%
4/20 • Number of events 6 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
15.0%
3/20 • Number of events 4 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry brittle finger nails
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Blisters
|
15.0%
3/20 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Bleeding
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • Number of events 7 • up to 24 months
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Cold hands and feet
|
5.0%
1/20 • Number of events 1 • up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place