Trial Outcomes & Findings for A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (NCT NCT05513742)
NCT ID: NCT05513742
Last Updated: 2026-07-28
Results Overview
Percentage of patients whose best overall response is assessed as complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Results posted on
2026-07-28
Participant Flow
The protocol required enrolment of approximately 40 (minimum of 37) response evaluable participants. A total of 49 participants were enrolled in Stage 1, yielding 40 response evaluable participants. The study results did not meet the protocol-defined criterion for progression to Stage 2, and thus enrollment ended after Stage 1.
Participant milestones
| Measure |
CTX-009 10 mg/kg
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
CTX-009 10 mg/kg
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Overall Study
Death
|
34
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Study termination by sponsor
|
7
|
Baseline Characteristics
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=20 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 11.54 • n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)Percentage of patients whose best overall response is assessed as complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Overall Response Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)Percentage of all treated patients whose best overall response was complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Disease Control Rate
|
28 Participants
|
SECONDARY outcome
Timeframe: From first date of complete or partial response to first date of disease progression or death (up to 15.4 weeks)Population: Calculated for patients who had confirmed complete or partial response
Time from the CT or MRI that first confirmed complete (CR) or partial response PR) to the CT or MRI that first confirmed progression of disease progression (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; PD = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=2 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Duration of Response
|
14.4 weeks
Interval 13.3 to 15.4
|
SECONDARY outcome
Timeframe: From first dose of CTX-009 to disease progression or death (up to 5.8 months)Time from first dose of CTX-009 to progression of disease or death. Progression of diseases is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Progression-free Survival
|
3.9 months
Interval 1.8 to 5.8
|
SECONDARY outcome
Timeframe: From first dose of CTX-009 to death (up to 17.8 months)Time from first dose of CTX-009 to death
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Overall Survival
|
10.2 Months
Interval 5.3 to 17.8
|
SECONDARY outcome
Timeframe: From the first CTX-009 dose to 30 days after the last CTX-009 dose (average 20 weeks) for TEAEs, from the first CTX-009 dose to 60 days after the last CTX-009 dose (average 25 weeks) for lab tests, vital signs, and ECGs.TEAE is defined by occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-009 through 30 days after the last dose of CTX-009. Change in clinical abnormalities is defined as an increase in abnormality grade in a laboratory result, vital sign, or ECG parameter from predose result to worst postdose result (graded according to the Common Terminology Criteria for Adverse Events v5.0 for all analytes except for brain natriuretic peptide and troponin subtypes, which are interpreted in reference to the laboratory reference range for each), a post-baseline potentially clinically significant vital sign abnormality, or a post-baseline potentially clinically significant ECG abnormality.
Outcome measures
| Measure |
CTX-009 10 mg/kg
n=49 Participants
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Aspartate aminotransferase increased: Grade 0 or 1 to Grade 2
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Blood bilirubin increased: Grade 0 or 1 to Grade 2
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Blood bilirubin increased: Grade 0 or 1 to Grade 3
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hypocalcemia: Grade 0 or 1 to Grade 2
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Creatinine increased: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyperglycemia: Grade 0 or 1 to Grade 2
|
13 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyperglycemia: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyperglycemia: Grade 2 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Lipase increased: Grade 0 or 1 to Grade 2
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Lipase increased: Grade 0 or 1 to Grade 3
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyperkalemia: Grade 0 or 1 to Grade 2
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyperkalemia: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyponatremia: Grade 0 or 1 to Grade 2
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hyponatremia: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Anemia: Grade 0 or 1 to Grade 2
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
White blood cell count decreased: Grade 0 or 1 to Grade 2
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Lymphocyte count decreased: Grade 0 or 1 to Grade 2
|
5 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Lymphocyte count decreased: Grade 2 to Grade 3
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Neutrophil count decreased: Grade 0 or 1 to Grade 2
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Platelet count decreased: Grade 0 or 1 to Grade 2
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Activated partial thromboplastin time prolonged: Grade 0 or 1 to Grade 2
|
4 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Proteinuria: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Proteinuria: Grade 2 to Grade 3
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Brain natriuretic peptide: Low or normal to high
|
16 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Troponin subtypes: Low or normal to high
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Systolic blood pressure >= 150 mmHg
|
35 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Systolic blood pressure =< 90 mmHg
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Diastolic blood pressure >= 100 mmHg
|
18 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
ECG QTcF interval > 450 msec
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
ECG QTcF interval =< 450 msec
|
49 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
ECG PR interval >= 200 msec
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
ECG QRS duration >= 120 msec
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
ECG heart rate >= 100 bpm
|
10 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Treatment-emergent adverse event
|
48 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Alanine aminotransferase increased: Grade 0 or 1 to Grade 3
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hypoalbuminemia: Grade 0 or 1 to Grade 2
|
7 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Alkaline phosphatase increased: Grade 0 or 1 to Grade 2
|
5 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Creatinine increased: Grade 0 or 1 to Grade 2
|
10 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Hypokalemia: Grade 0 or 1 to Grade 3
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Anemia: Grade 2 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Lymphocyte count decreased: Grade 0 or 1 to Grade 3
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Neutrophil count decreased: Grade 0 or 1 to Grade 3
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Neutrophil count decreased: Grade 0 or 1 to Grade 4
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
International normalized ratio increased: Grade 0 or 1 to Grade 2
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Proteinuria: Grade 0 or 1 to Grade 2
|
20 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Body temperature >= 38 C
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
Heart rate >= 100 bpm
|
28 Participants
|
Adverse Events
CTX-009 10 mg/kg
Serious events: 14 serious events
Other events: 47 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
CTX-009 10 mg/kg
n=49 participants at risk
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
4.1%
2/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Colitis
|
4.1%
2/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Enterovesical fistula
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Varices oesophageal
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Infections and infestations
Appendicitis
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.1%
2/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Nervous system disorders
Hyperammonaemic encephalopathy
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
General disorders
Sudden death
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
Other adverse events
| Measure |
CTX-009 10 mg/kg
n=49 participants at risk
10 mg/kg body weight by IV infusion over 1 hour every 2 weeks
|
|---|---|
|
Psychiatric disorders
Insomnia
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Psychiatric disorders
Anxiety
|
8.2%
4/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Nausea
|
28.6%
14/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
8/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Constipation
|
12.2%
6/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
6/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
General disorders
Ascites
|
8.2%
4/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Vascular disorders
Hypertension
|
44.9%
22/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
General disorders
Fatigue
|
26.5%
13/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
General disorders
Oedema peripheral
|
14.3%
7/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
General disorders
Early satiety
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Weight decreased
|
22.4%
11/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Aspartate aminotransferase increased
|
12.2%
6/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Blood alkaline phosphatase increased
|
10.2%
5/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
4/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Investigations
Blood creatinine increased
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Renal and urinary disorders
Proteinuria
|
36.7%
18/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.3%
8/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
7/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
6/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Nervous system disorders
Headache
|
20.4%
10/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Cardiac disorders
Cardiac failure
|
18.4%
9/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
4/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
|
Renal and urinary disorders
Urinary tract infection
|
6.1%
3/49 • From the signing of the informed consent form to 30 days after the last dose of CTX-009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees to withhold publication until after first multi-center publication or 18 months following study completion, whichever comes first. Additionally, the sponsor can review the results communications prior to public release and can embargo communications regarding the trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER