Trial Outcomes & Findings for Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours (NCT NCT02941523)
NCT ID: NCT02941523
Last Updated: 2021-06-02
Results Overview
Dose limiting toxicity during monotherapy and combination therapy defined as any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) (related to therapy) excluding Grade 3 or more neutropenia lasting greater than 5 days or thrombocytopenia associate with bleeding or Grade 4 thrombocytopenia.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 1 month for NOX66 monotherapy from enrollment and up to 7 months from start of NOX66 combination therapy
Results posted on
2021-06-02
Participant Flow
Participant milestones
| Measure |
NOX66 400 mg
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|
|
Monotherapy
STARTED
|
8
|
8
|
|
Monotherapy
COMPLETED
|
8
|
7
|
|
Monotherapy
NOT COMPLETED
|
0
|
1
|
|
Carboplatin Combination Therapy
STARTED
|
8
|
10
|
|
Carboplatin Combination Therapy
COMPLETED
|
3
|
6
|
|
Carboplatin Combination Therapy
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
NOX66 400 mg
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|
|
Monotherapy
Withdrawal by Subject
|
0
|
1
|
|
Carboplatin Combination Therapy
Adverse Event
|
0
|
1
|
|
Carboplatin Combination Therapy
Death
|
1
|
2
|
|
Carboplatin Combination Therapy
Disease progression
|
2
|
0
|
|
Carboplatin Combination Therapy
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours
Baseline characteristics by cohort
| Measure |
NOX66 400 mg
n=8 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg
n=11 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
Total
n=19 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
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 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
Georgia
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 month for NOX66 monotherapy from enrollment and up to 7 months from start of NOX66 combination therapyPopulation: All participants that received at least one dose of NOX66; 3 participants in 800 mg group did not receive monotherapy
Dose limiting toxicity during monotherapy and combination therapy defined as any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) (related to therapy) excluding Grade 3 or more neutropenia lasting greater than 5 days or thrombocytopenia associate with bleeding or Grade 4 thrombocytopenia.
Outcome measures
| Measure |
NOX66 400 mg Monotherapy
n=8 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 400 mg Combination Therapy
n=8 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg Monotherapy
n=7 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 800 mg Combination Therapy
n=10 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
Number of Participants Who Experience Dose Limiting Toxicity (DLT) During NOX66 Monotherapy and During NOX66 Combination With Carboplatin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From enrollment through 30 days after the last cycle of therapy (8 months)Population: Safety analyses set included all enrolled participants who received at least 1 dose of NOX66 or 1 dose NOX66 and carboplatin.
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.
Outcome measures
| Measure |
NOX66 400 mg Monotherapy
n=8 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 400 mg Combination Therapy
n=8 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg Monotherapy
n=7 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 800 mg Combination Therapy
n=10 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (SAEs) Related to NOX66.
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Radiological evaluation at baseline and at 3 months and at 6 monthsPopulation: Participants with measurable disease by RECIST v1.1 criteria at baseline and at 3 and 6 month post start of combination therapy.
Objective response rate defined as the percentage of participants achieving a complete response (CR) and or partial response (PR) after treatment with NOX66 and carboplatin therapy as assessed by Response Evaluation Criteria in solid tumors (RECIST) v1.1. CR defined as disappearance of all target and non-target lesions and reduction of any pathological lymph nodes (whether target or non-target) to \<10 mm in short axis; PR was defined by a 30% or more decrease in sum of longest diameter (SLD) of target lesions in reference to baseline. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and no new lesions.
Outcome measures
| Measure |
NOX66 400 mg Monotherapy
n=5 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 400 mg Combination Therapy
n=2 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg Monotherapy
n=9 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 800 mg Combination Therapy
n=6 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) at Cycle 3 and at Cycle 6 of Combination Therapy
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate (ORR) at Cycle 3 and at Cycle 6 of Combination Therapy
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Radiological evaluation at baseline and at 3 months and at 6 monthsPopulation: Participants with evaluable (measurable ) disease by RECIST v1.1 criteria at baseline and at 3 month and 6 month post combination therapy
Overall Clinical response rate defined as the percentage of participants who achieved complete response (CR) or partial response (PR) or stable disease (SD) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1 after combination of NOX66 and carboplatin therapy. CR defined as disappearance of all target and non-target lesions and reduction of any pathological lymph nodes (whether target or non-target) to \<10 mm in short axis; PR was defined by a 30% or more decrease in sum of longest diameter (SLD) of target lesions in reference to baseline. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
NOX66 400 mg Monotherapy
n=5 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 400 mg Combination Therapy
n=2 Participants
NOX66 400 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
NOX66 800 mg Monotherapy
n=9 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1)
|
NOX66 800 mg Combination Therapy
n=6 Participants
NOX66 800 mg administered daily for 14 days in a 21-day monotherapy (period 1) followed by 28-day combination therapy cycle (period 2) whereby NOX66 administered on days 1 to 7 and IV carboplatin on Day 2 in each cycle with 2 carboplatin doses low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
Overall Clinical Response Rate at Cycle 3 and at Cycle 6 of Combination Therapy
|
4 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Monotherapy Phase, NOX66 400 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Monotherapy Phase, NOX66 800 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Combination Phase, NOX66 400 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Combination Phase, NOX66 800 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Monotherapy Phase, NOX66 400 mg
n=8 participants at risk
NOX66 400 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
|
Monotherapy Phase, NOX66 800 mg
n=7 participants at risk
NOX66 800 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
|
Combination Phase, NOX66 400 mg
n=8 participants at risk
Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 400 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
Combination Phase, NOX66 800 mg
n=10 participants at risk
Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 800 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
General disorders
sudden death
|
0.00%
0/8 • 7 months
|
0.00%
0/3 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Injury, poisoning and procedural complications
Infusion reaction
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Nervous system disorders
Coma
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Gastrointestinal disorders
haemorrhage
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
Other adverse events
| Measure |
Monotherapy Phase, NOX66 400 mg
n=8 participants at risk
NOX66 400 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
|
Monotherapy Phase, NOX66 800 mg
n=7 participants at risk
NOX66 800 mg administered daily for 14 day in a 21-day monotherapy phase (period 1)
|
Combination Phase, NOX66 400 mg
n=8 participants at risk
Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 400 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
Combination Phase, NOX66 800 mg
n=10 participants at risk
Up to 6 cycles of a 28-day combination therapy cycle (period 2) with NOX66 800 mg administered daily on days 1 to 7 and IV carboplatin administered on Day 2 in each cycle with 2 carboplatin doses - low dose carboplatin AUC = 4 for treatment cycles 1-3 followed by higher dose carboplatin AUC = 6 for treatment cycles 4-6.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • 7 months
|
14.3%
1/7 • Number of events 1 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
30.0%
3/10 • Number of events 6 • 7 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 2 • 7 months
|
20.0%
2/10 • Number of events 7 • 7 months
|
|
Cardiac disorders
Pericarditis
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
0.00%
0/10 • 7 months
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 4 • 7 months
|
0.00%
0/10 • 7 months
|
|
General disorders
Asthenia
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 2 • 7 months
|
|
Investigations
Weight decreased
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
20.0%
2/10 • Number of events 2 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
|
Nervous system disorders
Neuropathy, peripheral
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/7 • 7 months
|
0.00%
0/8 • 7 months
|
0.00%
0/10 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
|
Vascular disorders
Embolism, arterial
|
0.00%
0/8 • 7 months
|
0.00%
0/7 • 7 months
|
12.5%
1/8 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60