Trial Outcomes & Findings for Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers (NCT NCT03332498)
NCT ID: NCT03332498
Last Updated: 2022-06-03
Results Overview
Standard 3+3 Design: The first cohort will enroll a minimum of 3 participants, according to a standard 3+3 design. If 0 out of the first 3 participants in the first cohort experience a dose-limiting toxicity (DLT), then dose escalation will continue as planned. If 1 out of the first 3 participants experience a DLT, then the cohort will be expanded to a total of 6 participants, and if no more than 1 out of 6 participants experiences a DLT in a given dose cohort, dose escalation will continue as planned. If ≥ 2 DLTs are observed in the first dose cohort, the principle investigator will discuss with Janssen on how to proceed. The DLT evaluation period will be defined as the time from the first dose of pembrolizumab and ibrutinib to 42 days after the first dose or if a participant experiences a DLT within this time period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
42 days post first dose
Results posted on
2022-06-03
Participant Flow
Participant milestones
| Measure |
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
|
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
|
Phase 2: Treatment at RP2D
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
32
|
|
Overall Study
COMPLETED
|
4
|
4
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
|
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
|
Phase 2: Treatment at RP2D
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|---|---|
|
Overall Study
Severe illness prior to Day 1 of treatment
|
0
|
0
|
2
|
Baseline Characteristics
Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers
Baseline characteristics by cohort
| Measure |
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 Participants
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
|
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 Participants
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
|
Phase 2: Treatment at RP2D
n=32 Participants
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
32 participants
n=27 Participants
|
40 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 42 days post first dosePopulation: All participants in Phase 1 portion of study who received at least one dose of study drugs
Standard 3+3 Design: The first cohort will enroll a minimum of 3 participants, according to a standard 3+3 design. If 0 out of the first 3 participants in the first cohort experience a dose-limiting toxicity (DLT), then dose escalation will continue as planned. If 1 out of the first 3 participants experience a DLT, then the cohort will be expanded to a total of 6 participants, and if no more than 1 out of 6 participants experiences a DLT in a given dose cohort, dose escalation will continue as planned. If ≥ 2 DLTs are observed in the first dose cohort, the principle investigator will discuss with Janssen on how to proceed. The DLT evaluation period will be defined as the time from the first dose of pembrolizumab and ibrutinib to 42 days after the first dose or if a participant experiences a DLT within this time period.
Outcome measures
| Measure |
Pembrolizumab and Ibrutinib
n=8 Participants
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W).
Ibrutinib by mouth (PO): Phase I Dose Escalation at doses of 420 mg daily (cohort 0) and 560 mg daily (cohort 1)
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|
|
Phase I - Recommended Phase II Dose (RP2D)
|
560 mg
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: All participants in Phase 2 portion who received at least one dose of study drugs.
Percentage of participants who achieved disease control at 4 months. Disease control rate = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST based immune-related response criteria (irRC).
Outcome measures
| Measure |
Pembrolizumab and Ibrutinib
n=31 Participants
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W).
Ibrutinib by mouth (PO): Phase I Dose Escalation at doses of 420 mg daily (cohort 0) and 560 mg daily (cohort 1)
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|
|
Phase II - Disease Control Rate at 4 Months
|
13 percentage of participants
|
Adverse Events
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 2: Treatment at RP2D
Serious events: 13 serious events
Other events: 29 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 participants at risk
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
|
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 participants at risk
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
|
Phase 2: Treatment at RP2D
n=32 participants at risk
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Rib pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Chest pain -cardiac
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Infections and Infestations - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Edma limbs
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Urinary tract infection-Pyelonephritis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Fever
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Fatigue
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Renal calculi
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Low colostomy output
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
Other adverse events
| Measure |
Phase 1 Cohort 0: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 participants at risk
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 420 mg daily.
|
Phase 1 Cohort 1: Dose Escalation (Pembrolizumab and Ibrutinib)
n=4 participants at risk
Pembrolizumab intravenously (IV): 200 mg every 3 weeks (Q3W). Ibrutinib by mouth (PO): Phase I Dose Escalation at 560 mg daily
|
Phase 2: Treatment at RP2D
n=32 participants at risk
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) - 200 mg Pembrolizumab and 560 mg Ibrutinib
Pembrolizumab: 200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
Ibrutinib: Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
|
|---|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
34.4%
11/32 • Number of events 11 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 12 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
28.1%
9/32 • Number of events 9 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 11 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
15.6%
5/32 • Number of events 5 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
CPK increased
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Creatinine increased
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
12.5%
4/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Serum amylase increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
INR increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Weight gain
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Weight loss
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
GGT increased
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Investigations
Investigations - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
34.4%
11/32 • Number of events 15 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
31.2%
10/32 • Number of events 11 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 9 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
21.9%
7/32 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
18.8%
6/32 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
28.1%
9/32 • Number of events 12 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 8 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
21.9%
7/32 • Number of events 8 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
18.8%
6/32 • Number of events 6 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
12.5%
4/32 • Number of events 5 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
2/4 • Number of events 5 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
2/4 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
75.0%
3/4 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
40.6%
13/32 • Number of events 15 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
15.6%
5/32 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
15.6%
5/32 • Number of events 5 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
General disorders and administration site conditions - Other
|
50.0%
2/4 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Chills
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Irritability
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
12.5%
4/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
15.6%
5/32 • Number of events 8 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
12.5%
4/32 • Number of events 6 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
75.0%
3/4 • Number of events 22 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
40.6%
13/32 • Number of events 21 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
21.9%
7/32 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
15.6%
5/32 • Number of events 5 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
21.9%
7/32 • Number of events 10 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
12.5%
4/32 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Parasthesia
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Memory impairment
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Nervous system disorders - Other
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 11 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
8/32 • Number of events 11 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
9.4%
3/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hot flashes
|
50.0%
2/4 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
18.8%
6/32 • Number of events 7 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Infections and infestations
Rash pustular
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
50.0%
2/4 • Number of events 4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
6.2%
2/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 3 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Cardiac disorders
Chest pain -cardiac
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 2 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
25.0%
1/4 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/32 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications -Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
0.00%
0/4 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
3.1%
1/32 • Number of events 1 • 1 year, 5 months
Includes only participants who received at least one dose of study drugs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place