Trial Outcomes & Findings for A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab (NCT NCT02978443)
NCT ID: NCT02978443
Last Updated: 2024-04-04
Results Overview
ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
24 months
Results posted on
2024-04-04
Participant Flow
Participant milestones
| Measure |
Nivolumab-Ipilimumab Combination Therapy
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Nivolumab-Ipilimumab Combination Therapy
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Disease Progression on study
|
6
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Switch to alternative therapy
|
1
|
|
Overall Study
Refused further treatment
|
1
|
Baseline Characteristics
A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
Baseline characteristics by cohort
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=14 Participants
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: patients with mucosal melanoma (MCM)
ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features
Outcome measures
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=9 Participants
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Objective Response Rate (ORR) With Mucosal Melanoma (MCM)
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: patients with with acral lentiginous melanoma (ALM)
ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features
Outcome measures
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=4 Participants
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Objective Response Rate With Acral Lentiginous Melanoma (ALM)
|
1 Participants
|
SECONDARY outcome
Timeframe: 33 monthsProgression-free survival is defined as the time from the date of treatment initiation until the date that disease progression criteria are met or the date death without progression, or is censored at the date of last disease assessment without evidence of progression.
Outcome measures
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=13 Participants
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Progression-free Survival (PFS)
|
127 days
Interval 12.0 to 995.0
|
SECONDARY outcome
Timeframe: 44 monthsOS is calculated from the date of treatment initiation to the date of death, or censored at date of last contact.
Outcome measures
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=13 Participants
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Overall Survival (OS)
|
567 days
Interval 12.0 to 1312.0
|
Adverse Events
Nivolumab-Ipilimumab Combination Therapy
Serious events: 7 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=13 participants at risk
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Infections and infestations
Anorectal infection
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Duodenal perforation
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Cardiac disorders
Heart failure
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Nervous system disorders
Syncope
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Infections and infestations
Wound infection
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
Other adverse events
| Measure |
Nivolumab-Ipilimumab Combination Therapy
n=13 participants at risk
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.
Nivolumab: nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.1%
3/13 • Number of events 4 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Anal pain
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13 • Number of events 5 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 3 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Fever
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Infusion related reaction
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Infections and infestations
Wound infection
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Alanine aminotransferase increased
|
38.5%
5/13 • Number of events 12 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Alkaline phosphatase increased
|
30.8%
4/13 • Number of events 4 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
4/13 • Number of events 6 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Renal and urinary disorders
Urinary urgency
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 3 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
3/13 • Number of events 3 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.8%
4/13 • Number of events 5 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Gastrointestinal disorders
Anal fistula
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders, other- specify
|
7.7%
1/13 • Number of events 1 • Adverse events were assessed from time of consent through 100 days of discontinuation of treatment; up to 1 year. All Cause mortality was assessed from start of treatment through up to 44 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place