Trial Outcomes & Findings for FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy (NCT NCT04491084)
NCT ID: NCT04491084
Last Updated: 2024-02-28
Results Overview
Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
up to 8 weeks after initiation of study therapy
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points.
FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs.
anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
Standard Care
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians.
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy
Baseline characteristics by cohort
| Measure |
FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT
n=2 Participants
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points.
FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs.
anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
Standard Care
n=3 Participants
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians.
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
Total
n=5 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Spanish/Hispanic/Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeks after initiation of study therapyPopulation: Data was not collected/aggregated. No analyses conducted.
Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks.Population: Data was not collected/aggregated. No analyses conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration until the date of death from any cause, assessed up to 2 yearsPopulation: Data was not collected/aggregated. No analyses conducted.
Length of time that patient survives from time of study registration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration, assessed up to 4 monthsPopulation: Data was not collected/aggregated. No analyses conducted.
The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected/aggregated. No analyses conducted.
Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected/aggregated. No analyses conducted.
Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected/aggregated. No analyses conducted.
Average daily step counts
Outcome measures
Outcome data not reported
Adverse Events
FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Standard Care
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT
n=2 participants at risk
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points.
FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs.
anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
Standard Care
n=3 participants at risk
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians.
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Infections and infestations
Lung Infection
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Nervous system disorders
Seizure
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Nervous system disorders
Muscle weakness left-sided
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Nervous system disorders
Dysarthria
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
Other adverse events
| Measure |
FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT
n=2 participants at risk
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points.
FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs.
anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
Standard Care
n=3 participants at risk
Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians.
SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • Number of events 8 • All participants enrolled in the trial were assessed through 49 weeks
|
66.7%
2/3 • Number of events 13 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Number of events 7 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Alkaline Phosphatase Increased
|
100.0%
2/2 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
100.0%
2/2 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
100.0%
2/2 • Number of events 7 • All participants enrolled in the trial were assessed through 49 weeks
|
66.7%
2/3 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 6 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/Shortness of Breath
|
100.0%
2/2 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
66.7%
2/3 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
General disorders
Fatigue/Weakness
|
100.0%
2/2 • Number of events 8 • All participants enrolled in the trial were assessed through 49 weeks
|
100.0%
3/3 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
66.7%
2/3 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Creatinine Increased
|
50.0%
1/2 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
66.7%
2/3 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
1/2 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Blood Bilirubin Increased
|
50.0%
1/2 • Number of events 7 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
GGT Increased
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
1/2 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Nervous system disorders
Slurred speech
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Left arm weakness
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
100.0%
2/2 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 4 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
1/2 • Number of events 2 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 5 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 3 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
0.00%
0/3 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
General disorders
Phlebitis
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • All participants enrolled in the trial were assessed through 49 weeks
|
33.3%
1/3 • Number of events 1 • All participants enrolled in the trial were assessed through 49 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place