Trial Outcomes & Findings for A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma (NCT NCT03999749)
NCT ID: NCT03999749
Last Updated: 2025-05-02
Results Overview
Adverse events are graded according to the NCI CTCAE version 5.0. Immune-related adverse events (irAEs) are specific events occurring within 100 days of the last dose (which includes pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine abnormalities \[adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis\]), regardless of causality, for which patients received immunosuppressive medication for treatment of the event. The exception to the immunosuppressive medication criteria for irAEs is endocrine events (e.g., hypothyroidism/thyroiditis, hyperthyroidism, hypophysitis, diabetes mellitus, adrenal insufficiency), which are included regardless of treatment since these events are often managed without immunosuppression.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
From start of treatment up to 100 days post treatment, *up to 18 months*
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
Induction Phase, Maintenance Phase
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the dose-limiting toxicity (DLT) period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Induction Phase, Maintenance Phase
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the dose-limiting toxicity (DLT) period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Overall Study
Toxicity
|
16
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Disease progression
|
26
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Death
|
5
|
|
Overall Study
Patient deemed ineligible after treatment
|
1
|
Baseline Characteristics
A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Induction Phase, Maintenance Phase
n=16 Participants
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 100 days post treatment, *up to 18 months*Adverse events are graded according to the NCI CTCAE version 5.0. Immune-related adverse events (irAEs) are specific events occurring within 100 days of the last dose (which includes pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine abnormalities \[adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis\]), regardless of causality, for which patients received immunosuppressive medication for treatment of the event. The exception to the immunosuppressive medication criteria for irAEs is endocrine events (e.g., hypothyroidism/thyroiditis, hyperthyroidism, hypophysitis, diabetes mellitus, adrenal insufficiency), which are included regardless of treatment since these events are often managed without immunosuppression.
Outcome measures
| Measure |
Induction Phase, Maintenance Phase
n=70 Participants
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Percentage of Participants With Grades 3-5 Treatment Related Immune Related Adverse Events (irAEs)
|
22.9 percentage of participants
Interval 13.7 to 34.5
|
PRIMARY outcome
Timeframe: Week 24Objective Response Rate (ORR) is defined as the total number of patients whose best response outcome is a CR or PR by week 24 divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Induction Phase, Maintenance Phase
n=70 Participants
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Objective Response Rate (ORR)
|
48.6 percentage of participants
Interval 36.5 to 60.9
|
SECONDARY outcome
Timeframe: From beginning of treatment until the first observation of disease progression (up to 5 years)Disease Control Rate (DCR) is defined as the total number of patients whose best response outcome is a complete response (CR) or partial response (PR), or SD divided by the total number of evaluable patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until the first observation of disease progression or death due to any cause, whichever came first (up to 5 years)Progression-Free Survival (PFS) is defined for each patient as the time from first dosing to the first observation of disease progression or death due to any cause. If a patient has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. Patients who do not have any tumor assessment on treatment will be censored on the day of the first dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of best overall response until the first observation of disease progression or death due to any cause, whichever came first (up to 5 years)Duration of Overall Response will be computed for all patients whose best response is either a PR or CR and is calculated from the time the measurement criteria are met for PR or CR, whichever is recorded first, until the date of documented PD or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until the first observation of disease progression (up to 5 years)Duration of Disease Control will be computed for the patients who had ORR outcome of CR, PR, or SD and is calculated from the beginning of treatment until the time of documented disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From beginning of treatment until the first observation of disease progression (up to 5 years)Immune-related Response Rate (irRR) is defined as the proportion of response evaluable patients whose Immune Related Best Overall Response (irBOR) outcome is irPR, irCR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From beginning of treatment until the first observation of disease progression (up to 5 years)Immune-related Disease Control Rate is defined as the proportion of the response evaluable patients whose irBOR outcome is irPR, irCR, or immune-related stable disease (irSD).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until the first observation of disease progression or death due to any cause, whichever came first (up to 5 years)Immune-related Progression-Free Survival (irPFS) is defined as the time between the first dosing date and the date of immune-related progressive disease (irPD) or death, whichever occurs first. For patients with no recorded post-baseline tumor assessment, irPFS will be censored at the day of first dose. A patient who dies without reported irPD will be considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS will be censored on the date of last evaluable tumor assessment. Patients who do not have any tumor assessment on treatment will be censored on the day of the first dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time irPR or irCR was met until the first observation of disease progression or death due to any cause, whichever came first (up to 5 years)Duration of Immune-related Overall Response will be computed for all patients whose irBOR outcome is either an irPR or irCR and is calculated from the time the measurement criteria are met for irPR or irCR, whichever is recorded first, until the date of documented PD or death by irRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From beginning of treatment until the first observation of disease progression (up to 5 years)Duration of Immune-related Disease Control will be computed for the patients who had irBOR outcome of irCR, irPR, or irSD and is calculated from the beginning of treatment until the time of documented disease progression by irRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment until the date of death from any cause (up to 5 years)Overall Survival is defined for each patient as the time from first dosing to death due to any cause. If a patient has not died at the time of analysis, OS will be censored as of their last known date alive (i.e. last time patient was contacted for any reason in the study). Patients who do not have any tumor assessment on treatment be followed up for OS, and their date of death will be incorporated into the OS analysis.
Outcome measures
Outcome data not reported
Adverse Events
Induction Phase, Maintenance Phase
Serious events: 34 serious events
Other events: 71 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Induction Phase, Maintenance Phase
n=71 participants at risk
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Adrenal Insufficiency
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Dislocated Iris
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Incarcerated Hernia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
ABD pain
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Colitis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Fatigue
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Weakness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Death
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Hepatobiliary disorders
Checkpoint inhibitor hepatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Hepatobiliary disorders
Immune Checkpoint Inhibitor Hepatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
COVID-19 infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
COVID-19 Pneumonia
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Lyme Disease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Cellulitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
UTI
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Lung Infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Sepsis
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Shingles
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Skin Infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
ALT increase
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Alkaline phosphate increase
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
AST increase
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Blood bilirubin increase
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Creatinine increase
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
GGT increase
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Lipase increase
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Lymphocyte count increase
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Neutrophil count decreased
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Platelet count decrease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Serum amylase increased
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Acidosis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle weakness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Headache
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Syncope
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Stroke
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Confusion
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Acute Kidney injury
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Adult respirartory distress syndrome
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Diffuse dermatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Incarcerated Hernia Repair
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Sinus Surgery with Septoplasty
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Hypotension
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Thromboembolic event
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Hot flashes
|
11.3%
8/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
Other adverse events
| Measure |
Induction Phase, Maintenance Phase
n=71 participants at risk
Induction Phase: 2 induction treatment cycles of 42 days (6 weeks) each, of which the first cycle of 6 weeks is the DLT period.
Maintenance Phase: Consists of treatment cycles of 84 days (12 weeks) each, and may extend up to 1 year.
Ipilimumab: 4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab: Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab: Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abnormal lymph nodes
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Post shingles neuropathy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Dizziness
|
22.5%
16/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Headache
|
28.2%
20/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Paresthesia
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Sciatica
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Concentration impairment
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Tremor
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Memory impairment
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Neuralgia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Lethargy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Dysgeusia
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Stroke
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Anemia
|
23.9%
17/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Transaminitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Hypovolemia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
increased L inguinal Lesion pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Hypertension
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Blood and lymphatic system disorders
Elevated Eosinophils
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Ventricular dysfunction with left ventricular hypertrophy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Reduced e' velocities on ECHO
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Palpatations
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Cyanosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Cardiac disorders
Chest Pain
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
impacted cerumen
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
Otitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
Hearing loss
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Ear and labyrinth disorders
Ear Pain
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Hypopituitarism
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Hypophysitis
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Testosterone deficiency
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Adrenal Insufficiency
|
9.9%
7/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Hyperthyroidism
|
11.3%
8/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Endocrine disorders
Hypothyroidism
|
15.5%
11/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Blurred vision
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Glaucoma
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Eye Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Uveitis
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Watering eyes
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Cataracts
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Photophobia
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Dry eyes
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Floaters
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Broken Blood vessel
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Eye Itching
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Ocular Migraine
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
R. Eye Stye
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
Eye Irritation
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Eye disorders
R. Eye Hordeolum
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Rectal Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Diarrhea
|
43.7%
31/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Enterocolitis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Constipation
|
19.7%
14/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Bloating
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
47.9%
34/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
ABD pain
|
19.7%
14/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Vomiting
|
14.1%
10/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Dry mouth
|
9.9%
7/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Stomach Pain
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Oral Pain
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Hematochezia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Tubular adenoma in colon
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Thickened Ileum
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Loose Stool
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Soft Stool
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Tooth Extraction
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Mouth Ulcers
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Left Upper Quadrant discomfort
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Phlegm
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Diverticulitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Barrett's Esophagus
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Motion sickness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Mouth sores
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Early Satiety
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Edema Limbs
|
22.5%
16/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Fatigue
|
56.3%
40/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Fever
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Night Sweats
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Injection site reaction
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Edema face
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Pain
|
23.9%
17/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Edema trunk
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Chills
|
9.9%
7/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Malaise
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Non-cardiac chest pain
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
R sided pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Localized edema
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Flu-like symptoms
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
R Arm pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
R Neck pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Groin Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Groin Abscess
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Post-op pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
R toe pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Leg pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Swelling
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Vaccination site lymphadenopathy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Left hip pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Injection realated reaction
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
COVID-19
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Intermittent hemoptysis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
General disorders
Weakness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Hepatobiliary disorders
Transaminitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Immune system disorders
Allergic reaction
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Immune system disorders
Allergic reaction to contrast
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Folliculitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Herpes Simplex reactivation
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Enterocolitis infectious
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Shingles
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Otitis externa
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Prostate infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Otitis media
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Lung infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Wound infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Vulval infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
UTI
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Upper Respiratory Infection
|
9.9%
7/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Tooth infection
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Papulopustular rash
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Skin Infection
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
COVID-19
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Diverticulitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Fungal infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
GI Virus
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Lower leg cellulitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Left foot fungal infection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Tinea Pedis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Left Mycotic Nail
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Lyme disease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Latent tuberculosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Influenza A
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Thrush
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Infusion related reacton
|
14.1%
10/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Seroma
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Umbilical Hernia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Pressure ulcers
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Left knee meniscus tear
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Dermatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Insect Bite
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Injury, poisoning and procedural complications
Steroid Withdrawal
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Activated partial thromboplastin prolonged
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
ALT increase
|
35.2%
25/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Alkaline phosphate increase
|
14.1%
10/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
AST increase
|
39.4%
28/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Blood bilirubin increase
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
LDH increase
|
15.5%
11/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Cardiac troponin T increase
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Cholesterol high
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Creatinine increase
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
GGT increase
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Lipase increase
|
25.4%
18/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Lymphocyte count decrease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Neutrophil count decreased
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Pancreatic enzymes decrease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Platelet count decrease
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Serum Amylase increase
|
25.4%
18/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Infections and infestations
Thyroid stimulating hormone increased
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Weight gain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Weight loss
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
White blood cell count decrease
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Headaches
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Investigations
Transaminitis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Acidosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Anorexia
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Dehydration
|
9.9%
7/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.3%
8/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.1%
15/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.5%
6/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.3%
8/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
R. Knee Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Left side Rib Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain from lung resection site
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
muscle cramp
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.3%
13/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
31.0%
22/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
8/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cyst
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Presumed Lipoma
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Lightheadedness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Nervous system disorders
Ulnar neuropathy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Mood changes
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Agitation
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Depression
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Insomnia
|
23.9%
17/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Anxiety
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Psychiatric disorders
Confusion
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Renal colic
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Glucosuria
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Cystitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urinary Retention
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urinary Hesitancy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Renal hesitancy
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Polyuria
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urine Discoloration
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urinary tract pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Urinary frequency
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Bilateral hydronephrosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Acute Kidney injury
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Reproductive system and breast disorders
Perineal soreness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Renal and urinary disorders
Cough
|
25.4%
18/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Breathing tightness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptom
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent hemoptysis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
5/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleaural Effusion
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Scalp abrasion
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Scalp lesion
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.2%
3/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Eczema Skin Roughness
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Lesions (axilla + breast)
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Micronodular BCC
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.6%
4/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Lichenoid dermatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Asteatotic dermatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Tick bite
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.7%
9/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Intertrigo groin
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Tinea corporis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Tinea pedis
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Hives
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Redness
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
16.9%
12/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
50.7%
36/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Fungal rash
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
43.7%
31/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
SCC left chest
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Eyelid skin tag
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Inflamed keratosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Grover's disease
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Sehorrheic keratosis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Diffuse dermatitis
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Left fore-arm nodule
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Lip nodule
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash from poison sumac
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
SCC
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Lung Resection
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Cataract
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Root canal
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Endoscopic retrograde cholangiopancreatography
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Surgical and medical procedures
Excision of ABD wall mass
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Flushing
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Hypertension
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Hypotension
|
2.8%
2/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Lymphedema
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
|
Vascular disorders
Right Lower Extremity DVT
|
1.4%
1/71 • AEs are assessed up to 59 weeks. SAEs are assessed up to 18 months. All-Cause Mortality is assessed up to 5 years.
PI monitors for AEs at every follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the Investigator. Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER