Trial Outcomes & Findings for Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC (NCT NCT04926831)
NCT ID: NCT04926831
Last Updated: 2025-10-16
Results Overview
The primary efficacy variable was MPR rate, defined as the proportion of participants with ≤ 10% residual viable cancer cells. MPR rate was to be assessed via local review for primary analysis. MPR assessment in tumor samples was collected at time of resection. Due to low number of participants and limited data, analysis related to the primary endpoint was not performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Baseline up to time of surgery (approximately 8 to 10 weeks after first dose)
Results posted on
2025-10-16
Participant Flow
This study was conducted at 3 centers in the USA.
Participant milestones
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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4
|
Reasons for withdrawal
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Adverse Event
|
2
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Baseline Characteristics
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
Baseline characteristics by cohort
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=4 Participants
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Age, Continuous
|
78.25 Years
n=5 Participants
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|
Sex: Female, Male
Female
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3 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to time of surgery (approximately 8 to 10 weeks after first dose)Population: All enrolled participants with tumor tissue samples
The primary efficacy variable was MPR rate, defined as the proportion of participants with ≤ 10% residual viable cancer cells. MPR rate was to be assessed via local review for primary analysis. MPR assessment in tumor samples was collected at time of resection. Due to low number of participants and limited data, analysis related to the primary endpoint was not performed.
Outcome measures
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=3 Participants
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Major Pathological Response (MPR) Rate
Responder as per local review
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1 Participants
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Major Pathological Response (MPR) Rate
Responder as per central review
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0 Participants
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SECONDARY outcome
Timeframe: Baseline up to time of surgery (approximately 8 - 10 weeks after first dose)Population: All enrolled participants with tumor tissue samples
Overall Response Rate (ORR) was defined as the percentage participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response ( PR) according to RECIST v1.1. BOR was the observed response at the assessment performed prior to surgery via local review.
Outcome measures
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=3 Participants
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Overall Response Rate (ORR)
|
1 Participants
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SECONDARY outcome
Timeframe: Baseline up to time of surgery (approximately. 8- 10 weeks after first dose)Population: All enrolled participants with tumor tissue samples
Complete pathologic response (pCR) rate ws defined as the percentage of participants with no residual viable cancer cells. pCR rate was assessed via both central and local review.
Outcome measures
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=3 Participants
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Complete Pathologic Response (pCR) Rate
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0 Participants
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SECONDARY outcome
Timeframe: From time of surgery to Months 24, 36, and 60Population: All enrolled participants. Due to early discontinuation of the study, no participants reached month 24 (no data was collected/analyzed for the endpoint).
Disease Free Survival (DFS) was defined as the time from the date of first adjuvant treatment to the date of the first documented disease recurrence as assessed by local investigator radiologically or death due to any cause. In case of non-conclusive radiological evidence, a biopsy was to be performed to confirm recurrence and used as DFS event. DFS events were assessed locally.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study medication, assessed up to approximately 20 monthsPopulation: All enrolled participants
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment emergent Adverse Event (TEAEs) in this study were events that started after the first dose of study treatment and until 30 days after the last dose of study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 30 days after the last study treatment.
Outcome measures
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=4 Participants
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
Adverse Events (AEs)
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4 Participants
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Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
AEs leading to study treatment discontinuation
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2 Participants
|
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Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
AEs leading to dose adjustment and/or interruption
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4 Participants
|
|
Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
Serious Adverse Events (SAEs)
|
3 Participants
|
|
Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
SAEs related to study treatment
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0 Participants
|
|
Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
Fatal SAEs
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1 Participants
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Adverse Events
Cohort A (MET Exon 14 Skipping Mutations)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=4 participants at risk
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Gastrointestinal disorders
Inguinal hernia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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Gastrointestinal disorders
Lower gastrointestinal haemorrhage
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25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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General disorders
Asthenia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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Nervous system disorders
Haemorrhage intracranial
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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|
Nervous system disorders
Syncope
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25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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Other adverse events
| Measure |
Cohort A (MET Exon 14 Skipping Mutations)
n=4 participants at risk
The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus arrest
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Hiatus hernia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Chills
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Generalised oedema
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Physical deconditioning
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
General disorders
Sensation of foreign body
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Escherichia urinary tract infection
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
Fibrin D dimer increased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
Troponin T increased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Vocal cord paralysis
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Psychiatric disorders
Sleep terror
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • On-treatment adverse events and deaths were reported from first dose of study medication up to 30 days after last dose of study medication, assessed up to approximately 20 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER