Trial Outcomes & Findings for Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma (NCT NCT02956382)
NCT ID: NCT02956382
Last Updated: 2025-07-18
Results Overview
The maximum tolerated dose of Ibrutinib and Venetoclax as determined by number of DLTs observed. • If 0/3 DLT is observed, dose escalation will continue to the next upper dose level. • If ≥ 2/3 DLTs are observed, then the dose finding procedure will be terminated. • If 1/3 DLT is observed, then 3 additional patients will be enrolled in the same dose level. If no DLT is observed from the additional 3 patients, then dose escalation will continue to the next upper dose level. If any DLT is observed from the 3 additional patients, then the previously lower dose will be chosen as the MTD and the dose finding procedure will be terminated.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Cycle 1 (28 days)
Results posted on
2025-07-18
Participant Flow
Participant milestones
| Measure |
Phase I - Dose Level 0
Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 1
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase II- Dose Level 2
The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion. Phase II Dose = Dose level 2, Ibrutinib (560mg), Venetoclax (600mg).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
1
|
8
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 0
n=3 Participants
Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 1
n=6 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=6 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase II Dose
n=8 Participants
The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)The maximum tolerated dose of Ibrutinib and Venetoclax as determined by number of DLTs observed. • If 0/3 DLT is observed, dose escalation will continue to the next upper dose level. • If ≥ 2/3 DLTs are observed, then the dose finding procedure will be terminated. • If 1/3 DLT is observed, then 3 additional patients will be enrolled in the same dose level. If no DLT is observed from the additional 3 patients, then dose escalation will continue to the next upper dose level. If any DLT is observed from the 3 additional patients, then the previously lower dose will be chosen as the MTD and the dose finding procedure will be terminated.
Outcome measures
| Measure |
Phase I - Dose Level 0
n=3 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
n=6 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=6 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D)
|
0 Dose Limiting toxicities
|
1 Dose Limiting toxicities
|
0 Dose Limiting toxicities
|
0 Dose Limiting toxicities
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Combined Phase I and Phase II participant on RP2D, Dose Level 2
Number of participants on the recommended phase II dose level 2, with a partial or complete response, as determined by the revised Lugano Response Criteria for Non-Hodgkin Lymphoma,
Outcome measures
| Measure |
Phase I - Dose Level 0
n=14 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Dose Level 2 Overall Response Rate
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (28 days)Cmax- Maximiumum concentration of Ibrutinib of subjects in Phase 1.
Outcome measures
| Measure |
Phase I - Dose Level 0
n=3 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
n=3 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=4 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Pharmacokinetics of Ibrutinib (Cmax) Phase 1
Cycle 1 Day 1
|
185 ng/mL
Standard Deviation 84.8
|
253 ng/mL
Standard Deviation 222
|
161 ng/mL
Standard Deviation 124
|
227 ng/mL
Standard Deviation 227
|
|
Pharmacokinetics of Ibrutinib (Cmax) Phase 1
Cycle 1 Day 15
|
155 ng/mL
Standard Deviation 4.00
|
195 ng/mL
Standard Deviation 109
|
181 ng/mL
Standard Deviation 105
|
199 ng/mL
Standard Deviation 199
|
SECONDARY outcome
Timeframe: Cycle 1 (28 days)Tmax (time to maximum) plasma concentrations of ibrutinib for subjects in phase 1
Outcome measures
| Measure |
Phase I - Dose Level 0
n=3 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
n=3 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=4 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Pharmacokinetics of Ibrutinib (Tmax) Phase 1
Cycle 1 Day 1
|
4 hours
Interval 2.0 to 4.0
|
2 hours
Interval 2.0 to 2.0
|
2 hours
Interval 1.0 to 2.0
|
2 hours
Interval 2.0 to 2.0
|
|
Pharmacokinetics of Ibrutinib (Tmax) Phase 1
Cycle 1 Day 15
|
2 hours
Interval 2.0 to 2.0
|
2 hours
Interval 2.0 to 2.0
|
2 hours
Interval 2.0 to 4.0
|
2 hours
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Cycle 1 (28 days)Area Under the Curve (AUC) 0 to 24 hours for subjects in phase 1
Outcome measures
| Measure |
Phase I - Dose Level 0
n=3 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
n=3 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=4 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Pharmacokinetics of Ibrutinib (AUC) Phase 1
Cycle 1 Day 1
|
1340 ng*h/mL
Standard Deviation 570
|
1420 ng*h/mL
Standard Deviation 1020
|
793 ng*h/mL
Standard Deviation 533
|
1980 ng*h/mL
Standard Deviation 1980
|
|
Pharmacokinetics of Ibrutinib (AUC) Phase 1
Cycle 1 Day 15
|
1180 ng*h/mL
Standard Deviation 244
|
1170 ng*h/mL
Standard Deviation 304
|
1250 ng*h/mL
Standard Deviation 912
|
2440 ng*h/mL
Standard Deviation 2440
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: All subjects who received dose level 2, regardless of the phase of the trial, phase 1 or phase 2, were combined since the adverse events are by dose level received not phase of the trial.
Toxicity (attribute and grade) will be summarized for each dose level (0, 1, 2, 3) for all patients who receive at least one dose of study treatment.
Outcome measures
| Measure |
Phase I - Dose Level 0
n=3 Participants
Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
|
Phase I - Dose Level 1
n=6 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 2
n=14 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase I - Dose Level 3
n=1 Participants
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg
Each medication is taken daily. Treatment cycles are 28 days long.
Ibrutinib: Ibrutinib is dispensed as a capsule.
Venetoclax: Venetoclax is dispensed as a tablet.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
|
3 Participants
|
6 Participants
|
14 Participants
|
1 Participants
|
Adverse Events
Phase 1- Dose Level 0
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 - Dose Level 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1 - Dose Level 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1- Dose Level 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase II- Dose Level 2
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1- Dose Level 0
n=3 participants at risk
Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1 - Dose Level 1
n=6 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1 - Dose Level 2
n=6 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1- Dose Level 3
n=1 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase II- Dose Level 2
n=8 participants at risk
The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion. Phase II Dose = Dose level 2, Ibrutinib (560mg), Venetoclax (600mg).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
Other adverse events
| Measure |
Phase 1- Dose Level 0
n=3 participants at risk
Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1 - Dose Level 1
n=6 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1 - Dose Level 2
n=6 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase 1- Dose Level 3
n=1 participants at risk
Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.
|
Phase II- Dose Level 2
n=8 participants at risk
The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion. Phase II Dose = Dose level 2, Ibrutinib (560mg), Venetoclax (600mg).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
66.7%
2/3 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders, Other, specify
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Eye disorders
Watering eyes
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
83.3%
5/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
83.3%
5/6 • Number of events 14 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
75.0%
6/8 • Number of events 12 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
37.5%
3/8 • Number of events 4 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Mucositis, oral
|
33.3%
1/3 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
83.3%
5/6 • Number of events 8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
66.7%
4/6 • Number of events 10 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
37.5%
3/8 • Number of events 8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
Chills
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 4 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
37.5%
3/8 • Number of events 4 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Fever
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Gastrointestinal disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
General disorders
Pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 4 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Infections and infestations
Upper respiratory infection
|
66.7%
2/3 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
83.3%
5/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
37.5%
3/8 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 7 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 5 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
Weight loss
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
37.5%
3/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 4 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
100.0%
1/1 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
50.0%
3/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
33.3%
2/6 • Number of events 3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/6 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
16.7%
1/6 • Number of events 1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/1 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
0.00%
0/8 • From the time of consent to 30 days after discontinuation of treatment (3.5 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place