Trial Outcomes & Findings for Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma (NCT NCT02142049)
NCT ID: NCT02142049
Last Updated: 2019-02-05
Results Overview
Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
1 year after last subjects received the first dose
Results posted on
2019-02-05
Participant Flow
Participant milestones
| Measure |
Part 1: Dose Level 1
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 2: RP2D
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
20
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Part 1: Dose Level 1
n=3 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
n=6 Participants
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 2: RP2D
n=20 Participants
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Total
n=35 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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
58 years
n=7 Participants
|
67 years
n=5 Participants
|
55 years
n=4 Participants
|
59 years
n=21 Participants
|
58 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
29 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
20 participants
n=21 Participants
|
35 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 year after last subjects received the first dosePart-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R
Outcome measures
| Measure |
Part 1: Dose Level 1
n=3 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
n=6 Participants
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
n=15 Participants
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 year after last subjects received the first dosePart 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.
Outcome measures
| Measure |
Part 1: Dose Level 1
n=26 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=14 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR
|
16 Participants
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year after last subjects received the first dosePart-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.
Outcome measures
| Measure |
Part 1: Dose Level 1
n=3 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
n=3 Participants
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
n=6 Participants
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
n=15 Participants
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year after last subjects received the first dosePart 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.
Outcome measures
| Measure |
Part 1: Dose Level 1
n=26 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=14 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
|
26 Participants
|
14 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.
Outcome measures
| Measure |
Part 1: Dose Level 1
n=26 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=14 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy
Progression Free Survival (PFS)
|
4.86 Months
Interval 0.03 to 12.45
|
4.86 Months
Interval 0.03 to 9.69
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy
Overall Survival (OS)
|
15.84 Months
Interval 0.26 to 28.22
|
15.84 Months
Interval 0.26 to 28.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Part 1: Dose Level 1
n=16 Participants
Ibrutinib 560 mg PO + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=9 Participants
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: All Treated
Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
3.94 Months
Interval 0.03 to 10.48
|
4.09 Months
Interval 0.03 to 7.69
|
—
|
—
|
—
|
Adverse Events
Part 1: Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1: Dose Level 2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1: Dose Level 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1: Dose Level 4
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
All Subjects Treated at RP2D
Serious events: 19 serious events
Other events: 26 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1: Dose Level 1
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 0 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 15 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 20 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
n=6 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 25 mg (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
All Subjects Treated at RP2D
n=26 participants at risk
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
23.1%
6/26 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
General disorders
Death
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 3 • 3 years
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Infections and infestations
Septic shock
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
3.8%
1/26 • Number of events 2 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
7.7%
2/26 • Number of events 3 • 3 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
Other adverse events
| Measure |
Part 1: Dose Level 1
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 0 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 2
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 15 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 3
n=3 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 20 (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
Part 1: Dose Level 4
n=6 participants at risk
Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 25 mg (PO)
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
All Subjects Treated at RP2D
n=26 participants at risk
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 3 years
|
100.0%
3/3 • Number of events 5 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • Number of events 11 • 3 years
|
100.0%
3/3 • Number of events 29 • 3 years
|
66.7%
2/3 • Number of events 22 • 3 years
|
66.7%
4/6 • Number of events 16 • 3 years
|
46.2%
12/26 • Number of events 42 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
3/3 • Number of events 12 • 3 years
|
33.3%
1/3 • Number of events 4 • 3 years
|
33.3%
1/3 • Number of events 7 • 3 years
|
50.0%
3/6 • Number of events 6 • 3 years
|
46.2%
12/26 • Number of events 28 • 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 4 • 3 years
|
33.3%
1/3 • Number of events 5 • 3 years
|
33.3%
2/6 • Number of events 5 • 3 years
|
15.4%
4/26 • Number of events 11 • 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 5 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 6 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
23.1%
6/26 • Number of events 11 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
66.7%
4/6 • Number of events 4 • 3 years
|
19.2%
5/26 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 13 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 3 years
|
100.0%
3/3 • Number of events 9 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
50.0%
3/6 • Number of events 3 • 3 years
|
23.1%
6/26 • Number of events 6 • 3 years
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Cardiac disorders
Mitral valve incompetence
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 4 • 3 years
|
100.0%
3/3 • Number of events 10 • 3 years
|
33.3%
1/3 • Number of events 6 • 3 years
|
83.3%
5/6 • Number of events 7 • 3 years
|
46.2%
12/26 • Number of events 21 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 3 • 3 years
|
100.0%
3/3 • Number of events 11 • 3 years
|
66.7%
2/3 • Number of events 4 • 3 years
|
50.0%
3/6 • Number of events 5 • 3 years
|
42.3%
11/26 • Number of events 17 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 3 • 3 years
|
66.7%
2/3 • Number of events 8 • 3 years
|
83.3%
5/6 • Number of events 9 • 3 years
|
57.7%
15/26 • Number of events 24 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
2/6 • Number of events 5 • 3 years
|
15.4%
4/26 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
7.7%
2/26 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastric polyps
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
15.4%
4/26 • Number of events 9 • 3 years
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • 3 years
|
100.0%
3/3 • Number of events 17 • 3 years
|
33.3%
1/3 • Number of events 5 • 3 years
|
83.3%
5/6 • Number of events 6 • 3 years
|
50.0%
13/26 • Number of events 16 • 3 years
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • 3 years
|
100.0%
3/3 • Number of events 8 • 3 years
|
100.0%
3/3 • Number of events 4 • 3 years
|
33.3%
2/6 • Number of events 3 • 3 years
|
26.9%
7/26 • Number of events 8 • 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 4 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 3 • 3 years
|
19.2%
5/26 • Number of events 6 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 3 • 3 years
|
11.5%
3/26 • Number of events 4 • 3 years
|
|
General disorders
Pain
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
General disorders
Asthenia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
General disorders
Chills
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
General disorders
Injection site haematoma
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
General disorders
Oedema
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Immune system disorders
Hypogammaglobulinaemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 4 • 3 years
|
7.7%
2/26 • Number of events 5 • 3 years
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Laceration
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 2 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 4 • 3 years
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 3 • 3 years
|
66.7%
2/3 • Number of events 8 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 19 • 3 years
|
33.3%
1/3 • Number of events 6 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
15.4%
4/26 • Number of events 6 • 3 years
|
|
Investigations
Weight increased
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 3 • 3 years
|
3.8%
1/26 • Number of events 3 • 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 7 • 3 years
|
66.7%
2/3 • Number of events 7 • 3 years
|
33.3%
2/6 • Number of events 20 • 3 years
|
42.3%
11/26 • Number of events 42 • 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 3 • 3 years
|
66.7%
2/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
2/6 • Number of events 3 • 3 years
|
19.2%
5/26 • Number of events 6 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
50.0%
3/6 • Number of events 3 • 3 years
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 8 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
11.5%
3/26 • Number of events 6 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 7 • 3 years
|
33.3%
1/3 • Number of events 15 • 3 years
|
33.3%
1/3 • Number of events 13 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
15.4%
4/26 • Number of events 16 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
2/6 • Number of events 3 • 3 years
|
19.2%
5/26 • Number of events 9 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 6 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
19.2%
5/26 • Number of events 6 • 3 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 4 • 3 years
|
11.5%
3/26 • Number of events 6 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
15.4%
4/26 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 6 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
23.1%
6/26 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 4 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 4 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 3 years
|
100.0%
3/3 • Number of events 6 • 3 years
|
66.7%
2/3 • Number of events 2 • 3 years
|
50.0%
3/6 • Number of events 6 • 3 years
|
30.8%
8/26 • Number of events 16 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 6 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
23.1%
6/26 • Number of events 7 • 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
23.1%
6/26 • Number of events 6 • 3 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
11.5%
3/26 • Number of events 3 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 5 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Peroneal nerve palsy
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 5 • 3 years
|
66.7%
2/3 • Number of events 4 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
19.2%
5/26 • Number of events 6 • 3 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
15.4%
4/26 • Number of events 4 • 3 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • 3 years
|
66.7%
2/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Delusion
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 4 • 3 years
|
3.8%
1/26 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
66.7%
2/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 2 • 3 years
|
15.4%
4/26 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 3 years
|
66.7%
2/3 • Number of events 4 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Number of events 1 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
2/6 • Number of events 2 • 3 years
|
19.2%
5/26 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
16.7%
1/6 • Number of events 1 • 3 years
|
3.8%
1/26 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 3 years
|
100.0%
3/3 • Number of events 3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
50.0%
3/6 • Number of events 4 • 3 years
|
23.1%
6/26 • Number of events 7 • 3 years
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 5 • 3 years
|
66.7%
2/3 • Number of events 12 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 2 • 3 years
|
0.00%
0/3 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
|
Vascular disorders
Jugular vein distension
|
0.00%
0/3 • 3 years
|
0.00%
0/3 • 3 years
|
33.3%
1/3 • Number of events 1 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/26 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place