Trial Outcomes & Findings for Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC (NCT NCT03181308)
NCT ID: NCT03181308
Last Updated: 2020-06-24
Results Overview
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, Febrile neutropenia: Grade 4 neutropenia with fever \>38.5ºC both sustained over a ≥24-hour period, neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, Grade ≥4 thrombocytopenia or Grade ≥3 thrombocytopenia with Grade ≥3 hemorrhage, or grade 3 or 4 nonhematologic toxicity with the following exceptions: asymptomatic electrolyte abnormality that is corrected to Grade 1 or better in \<72 hours, grade 3 headache lasting \<48 hours. See protocol for Immune related DLT criteria.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Approximately 2-8 months
Results posted on
2020-06-24
Participant Flow
Participant milestones
| Measure |
8 mg/kg TRC105 + Nivolumab
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
|
Overall Study
COMPLETED
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
8 mg/kg TRC105 Plus Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 Plus Nivolumab
n=8 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
59 years
n=107 Participants
|
59 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 2-8 monthsPopulation: All patients who received at least a portion of a dose of any study drug (TRC105, Nivolumab)
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, Febrile neutropenia: Grade 4 neutropenia with fever \>38.5ºC both sustained over a ≥24-hour period, neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, Grade ≥4 thrombocytopenia or Grade ≥3 thrombocytopenia with Grade ≥3 hemorrhage, or grade 3 or 4 nonhematologic toxicity with the following exceptions: asymptomatic electrolyte abnormality that is corrected to Grade 1 or better in \<72 hours, grade 3 headache lasting \<48 hours. See protocol for Immune related DLT criteria.
Outcome measures
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=8 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Patients with DLT at 8 mg/kg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Patients without DLT at 8 mg/kg
|
3 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Patients with DLT at 10 mg/kg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Patients without DLT at 10 mg/kg
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Approximately 2-8 monthsPopulation: Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination. Patients were scanned at baseline and every 8 weeks to determine disease status.
Preliminary evidence of antitumor activity of carotuximab (TRC105) plus nivolumab will be evaluated, by assessing response rate and progression-free survival. The best response was measured to iRECIST by MRI or CT scans for each patient with measurable disease who received at least 1 dose of study drug.
Outcome measures
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=7 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Response Rate
iSD (Immune Stable Disease) Best Response
|
0 participants
|
4 participants
|
|
Response Rate
iPR (Immune Partial Response) Best Response
|
1 participants
|
0 participants
|
|
Response Rate
iPD (Immune Progressive Disease) Best Response
|
0 participants
|
0 participants
|
|
Response Rate
iCR (Immune Complete Response) Best Response
|
0 participants
|
0 participants
|
|
Response Rate
iUPD (Unconfirmed Immune PD) Best Response
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study. 6 patients had PK analysis completed.
Trough (pre-dose) serum carotuximab (TRC105) concentrations will be measured using validated ELISA methods.
Outcome measures
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Trough Carotuximab (TRC105) Concentrations
|
65233 ng/ml
Interval 46400.0 to 82700.0
|
93600 ng/ml
Interval 72600.0 to 121000.0
|
SECONDARY outcome
Timeframe: Approximately 2-8 monthsPopulation: Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
Number of Participants with carotuximab (TRC105) anti-product antibodies (APA)
Outcome measures
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Development of Immunogenicity Antibodies
Ptn with low titer treatment emergent ADA
|
0 Participants
|
0 Participants
|
|
Development of Immunogenicity Antibodies
Ptn without treatment emergent ADA
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Approximately 2-8 monthsPopulation: All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study. Only Cycle 2 Day 1 trough mean serum TRC105 concentrations were analyzed before study closure.
Trough (pre-dose) serum nivolumab concentrations will be measured using validated ELISA methods.
Outcome measures
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=3 Participants
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Trough Nivolumab Concentrations
|
65233 ng/ml
Interval 46400.0 to 82700.0
|
93600 ng/ml
Interval 72600.0 to 121000.0
|
Adverse Events
8 mg/kg TRC105 + Nivolumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mg/kg TRC105 + Nivolumab
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 participants at risk
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=8 participants at risk
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Vascular access complication
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
Other adverse events
| Measure |
8 mg/kg TRC105 + Nivolumab
n=3 participants at risk
Dose Level 1 8 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
10 mg/kg TRC105 + Nivolumab
n=8 participants at risk
Dose Level 2 10 mg/kg TRC105 + Nivolumab
Carotuximab (TRC105): Anti Endoglin Antibody
OPDIVO (Nivolumab): Programmed Death Receptor-1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Blindness transient
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Retinal tear
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
66.7%
2/3 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Face oedema
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
37.5%
3/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
37.5%
3/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
75.0%
6/8 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Migraine
|
66.7%
2/3 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Sinus headache
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
4/8 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
66.7%
2/3 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
25.0%
2/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
100.0%
3/3 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Embolism
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
37.5%
3/8 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/8 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • From screening until completion of follow-up, on average 6 months
|
12.5%
1/8 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place