Trial Outcomes & Findings for Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC (NCT NCT03425331)
NCT ID: NCT03425331
Last Updated: 2026-01-08
Results Overview
Best response on treatment is based on RECISTv1.1 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Both require confirmation no fewer than 4 weeks apart. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must also demonstrate an absolute increase of at least 5 mm since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD) is defined as any condition not meeting the above criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).
Results posted on
2026-01-08
Participant Flow
Participants were enrolled from 04/2018 to 11/2018.
Participant milestones
| Measure |
Nivolumab+Ipilimumab
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Nivolumab+Ipilimumab
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC
Baseline characteristics by cohort
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Age, Continuous
|
59.80 years
STANDARD_DEVIATION 9.34 • n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).Best response on treatment is based on RECISTv1.1 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Both require confirmation no fewer than 4 weeks apart. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must also demonstrate an absolute increase of at least 5 mm since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD) is defined as any condition not meeting the above criteria.
Outcome measures
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Best Response
Partial Response
|
3 Participants
|
|
Best Response
Stable Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Disease was evaluated at baseline and then every 6 weeks for the first 6 cycles of therapy and in long-term follow-up every 3 months. Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).PFS based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) defined per RECIST 1.1 criteria or death, or is censored at time of last disease assessment.
Outcome measures
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Median Progression-free Survival (PFS)
|
6.90 months
Interval 4.01 to
There are only 3 events, therefore the upper limit of the 90% CI is not finite.
|
SECONDARY outcome
Timeframe: Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Outcome measures
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Median Overall Survival (OS)
|
15.97 months
Interval 15.31 to
There are only 3 events, therefore the upper limit of the 90% CI is not finite.
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).DOR, estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without PD are censored at the date of last disease assessment.
Outcome measures
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Median Duration of Response (DOR)
|
4.11 months
Interval 2.74 to 8.39
|
SECONDARY outcome
Timeframe: AE evaluated on day 1, 15, 29 each cycle. The median of treatment duration is 8.05 months with range (2.76 months - 15.90 months).All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Outcome measures
| Measure |
Nivolumab+Ipilimumab
n=5 Participants
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Incidence of Grade 4-5 Treatment-related Toxicity Rate
|
0.2 proportion of participants
|
Adverse Events
Nivolumab+Ipilimumab
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Nivolumab+Ipilimumab
n=5 participants at risk
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Fever
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
Other adverse events
| Measure |
Nivolumab+Ipilimumab
n=5 participants at risk
Nivolumab will be administered once every 2 weeks at a dosage of 3 mg/kg intravenously, and Ipilimumab will be administered once every 6 weeks at a dosage of 1 mg/kg intravenously
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Eye disorders
Conjunctivitis
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Edema limbs
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Fatigue
|
60.0%
3/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Fever
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
60.0%
3/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
General disorders and administration site conditions
Pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Infections and infestations
Bronchial infection
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Cholesterol high
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Lipase increased
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Serum amylase increased
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Weight gain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Investigations
Weight loss
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Psychiatric disorders
Confusion
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Psychiatric disorders
Depression
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Psychiatric disorders
Insomnia
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Renal and urinary disorders
Urinary tract pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
|
|
Vascular disorders
Thromboembolic event
|
40.0%
2/5 • AE evaluated on day 1, 15, 29 each cycle on treatment. The median of the observation period for all-cause mortality is 15.97 months with range (4.00 months - 20.63 months). The median of observation time for AE is 8.05 months with range (2.76 months - 15.90 months).
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event, requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, suspected transmission of an infectious agent via the study drug is an SAE
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place