Trial Outcomes & Findings for Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer. (NCT NCT03262779)
NCT ID: NCT03262779
Last Updated: 2025-01-09
Results Overview
Objective response is defined as a complete or partial response, as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 confirmed by repeat assessment ≥4 weeks after initial documentation. The categories are: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Tumor response assessment will occur every 9 weeks after initiating trial therapy for the first 24 weeks, and thereafter every 12 weeks until disease progression or up to 4 years.
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Combination Nivolumab and Ipilimumab - Primary
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Eligible for Biopsy
|
7
|
7
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer.
Baseline characteristics by cohort
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
64.5 years
n=7 Participants
|
68.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor response assessment will occur every 9 weeks after initiating trial therapy for the first 24 weeks, and thereafter every 12 weeks until disease progression or up to 4 years.Population: Patients that completed treatment.
Objective response is defined as a complete or partial response, as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 confirmed by repeat assessment ≥4 weeks after initial documentation. The categories are: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Objective Response Rate Using RECIST v1.1 to Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre-treated Advanced NSCLC Who Have Experienced Primary Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
complete response (CR)
|
0 Participants
|
—
|
|
Objective Response Rate Using RECIST v1.1 to Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre-treated Advanced NSCLC Who Have Experienced Primary Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
partial response (PR)
|
0 Participants
|
—
|
|
Objective Response Rate Using RECIST v1.1 to Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre-treated Advanced NSCLC Who Have Experienced Primary Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
stable disease (SD)
|
2 Participants
|
—
|
|
Objective Response Rate Using RECIST v1.1 to Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre-treated Advanced NSCLC Who Have Experienced Primary Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
progressive disease (PD)
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Tumor response assessment will occur every 9 weeks after initiating trial therapy for the first 24 weeks, and thereafter every 12 weeks, up to four years.Population: Patients with advanced non-small cell lung cancer (NSCLC) with ACQUIRED resistance to anti-programmed death (PD)-1 axis therapy as their last line of systemic therapy.
Objective response is defined as a complete or partial response, as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and confirmed by repeat assessment ≥4 weeks after initial documentation. The categories are: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). This outcome is only presented for those with advanced non-small cell lung cancer (NSCLC) with ACQUIRED resistance to anti-programmed death (PD)-1 axis therapy as their last line of systemic therapy.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Objective Response Rate in in Advanced Non-small Cell Lung Cancer (NSCLC) With ACQUIRED Resistance to Anti-programmed Death (PD)-1 Axis Therapy as Their Last Line of Systemic Therapy.
complete response (CR)
|
1 Participants
|
—
|
|
Objective Response Rate in in Advanced Non-small Cell Lung Cancer (NSCLC) With ACQUIRED Resistance to Anti-programmed Death (PD)-1 Axis Therapy as Their Last Line of Systemic Therapy.
partial response (PR)
|
0 Participants
|
—
|
|
Objective Response Rate in in Advanced Non-small Cell Lung Cancer (NSCLC) With ACQUIRED Resistance to Anti-programmed Death (PD)-1 Axis Therapy as Their Last Line of Systemic Therapy.
stable disease (SD)
|
8 Participants
|
—
|
|
Objective Response Rate in in Advanced Non-small Cell Lung Cancer (NSCLC) With ACQUIRED Resistance to Anti-programmed Death (PD)-1 Axis Therapy as Their Last Line of Systemic Therapy.
progressive disease (PD)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Until disease progression, unacceptable toxicity, or study termination, up to four years.Population: Patients pre-treated with advanced NSCLC who have experienced primary resistance to anti-PD-1 axis therapy as their last line of systemic therapy.
Progression free survival is defined as the time from the first day of nivolumab treatment until progression of disease using RECIST v1.1. This outcome is only presented for those pre-treated with advanced NSCLC who have experienced primary resistance to anti-PD-1 axis therapy as their last line of systemic therapy.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Progression-free Survival With Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre- Treated Advanced NSCLC Who Have Experienced Primary Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy
|
1.8 months
Interval 1.4 to 4.2
|
—
|
SECONDARY outcome
Timeframe: Until disease progression, unacceptable toxicity, or study termination, up to four years from enrollment.Population: Patients that completed treatment.
Progression free survival is defined as the time from the first day of nivolumab treatment until progression of disease using RECIST v1.1 and immune related Response Criteria. This is in those that have experienced acquired resistance to anti-PD-1 axis therapy as their last line of systemic therapy.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Progression Free Survival by RECIST v1.1 With Nivolumab and Ipilimumab in Patients With Pre-treated Advanced NSCLC Who Have Experienced Acquired Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
|
6.8 months
Interval 1.8 to 28.7
|
—
|
SECONDARY outcome
Timeframe: Until death or day of last follow-up, up to four years from enrollment.Population: Patients that completed treatment.
Overall survival is defined as the time from the first day of treatment until death from any cause. If a patient has not experienced death, OS will be censored at the day of last follow-up. This is in patients that have experienced PRIMARY resistance to anti-PD-1 axis therapy as their last line of systemic therapy.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Overall Survival (OS) With Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre- Treated Advanced NSCLC Who Have Experienced PRIMARY Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
|
6.8 months
Interval 1.7 to 17.8
|
—
|
SECONDARY outcome
Timeframe: Until death or day of last follow-up (up to four years from study enrollment).Population: Patients that have completed treatment.
Overall survival is defined as the time from the first day of treatment until death from any cause. If a patient has not experienced death, OS will be censored at the day of last follow-up.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Overall Survival With Nivolumab and Ipilimumab in Patients With Pre-treated Advanced NSCLC Who Have Experienced ACQUIRED Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
|
24.7 months
Interval 7.5 to 48.5
|
—
|
SECONDARY outcome
Timeframe: Tumor response assessment will occur every 9 weeks after initiating trial therapy for the first 24 weeks, and thereafter every 12 weeks, up to four years.Objective response is defined as a complete or partial response, as determined by investigator assessment using irRC and confirmed by repeat assessment ≥4 weeks after initial documentation.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Objective Response Rate Using irRC to Nivolumab and Ipilimumab When Administered in Combination to Patients With Pre-treated Advanced NSCLC Who Have Experienced PRIMARY or ACQUIRED Resistance to Anti-PD-1 Axis Therapy as Last Line of Systemic Therapy.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsDetermined based on adverse events which will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. Presented are a count of those that experienced at least 1 Serious Adverse Event related to study drug.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
n=10 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Safety of Nivolumab and Ipilimumab When Administered in Combination in Patients With Pre-treated Advanced NSCLC Who Have Experienced PRIMARY or ACQUIRED Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Tumor biopsies performed at 9 to 10 weeks after receiving first dose of trial therapy.Population: Only those that were eligible for biopsy at 9-10 weeks.
Feasibility of sequential biopsies (performed or not performed) in patients with pre-treated advanced NSCLC who have experienced PRIMARY or ACQUIRED resistance to anti-PD-1 axis therapy as their last line of systemic therapy. Presented are a count of those that had biopsies performed or not performed.
Outcome measures
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=7 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
|
Combination Nivolumab and Ipilimumab - Acquired
n=7 Participants
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
|
|---|---|---|
|
Feasibility of Sequential Biopsies in Patients With Pre-treated Advanced NSCLC Who Have Experienced PRIMARY or ACQUIRED Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
performed
|
4 Participants
|
4 Participants
|
|
Feasibility of Sequential Biopsies in Patients With Pre-treated Advanced NSCLC Who Have Experienced PRIMARY or ACQUIRED Resistance to Anti-PD-1 Axis Therapy as Their Last Line of Systemic Therapy.
not performed
|
3 Participants
|
3 Participants
|
Adverse Events
Combination Nivolumab and Ipilimumab - Primary
Serious events: 3 serious events
Other events: 10 other events
Deaths: 10 deaths
Combination Nivolumab and Ipilimumab - Acquired
Serious events: 2 serious events
Other events: 10 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 participants at risk
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
Combination Nivolumab and Ipilimumab - Acquired
n=10 participants at risk
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
|---|---|---|
|
Infections and infestations
Autoimmune Encephalitis
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Cardiac disorders
Cardiac Arrest
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Infections and infestations
Lung Infection
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 5 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Stroke
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Surgical and medical procedures
Parietal craniotomy
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Radiation necrosis
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
Other adverse events
| Measure |
Combination Nivolumab and Ipilimumab - Primary
n=10 participants at risk
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with primary resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
Combination Nivolumab and Ipilimumab - Acquired
n=10 participants at risk
Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, and ipilimumab 1 mg/kg administered IV every 6 weeks in patients with acquired resistance.
combination nivolumab and ipilimumab: Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 4 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
4/10 • Number of events 4 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders -Other
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 8 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 4 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 4 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 4 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
40.0%
4/10 • Number of events 12 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
General disorders
General disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 5 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Nervous system disorders - Other
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
30.0%
3/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Stroke
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Eye disorders
Blurred vision
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 6 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Vascular disorders
Hot Flashes
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Gastrointestinal disorders
Rectal pain
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 2 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
20.0%
2/10 • Number of events 3 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
10.0%
1/10 • Number of events 1 • Up to 4 years
Originally reported were deaths that occurred during treatment or within 30 days of treatment, the all cause mortality was updated to reflect a longer follow up time period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place