Trial Outcomes & Findings for Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease (NCT NCT01680965)
NCT ID: NCT01680965
Last Updated: 2022-10-06
Results Overview
Maximum Tolerated Dose was determined by increasing doses, beginning at 300 mg on day 0 and day 14, then increasing to 700 mg on day 0 and day 14 and finally 1000 mg on day 0 and day 14.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
within 21 days of initiation
Results posted on
2022-10-06
Participant Flow
Participant milestones
| Measure |
Phase 1 Cohort 1:Ofatumumab
Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 2: Ofatumumab
Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
|
Phase1 Cohort 3
Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
|
Phase 2: Maximum Tolerated Dose of Ofatumumab
Phase II: Maximum tolerated dose (MTD) of Ofatumumab
Ofatumumab at 1000 mg on day 0 and 14
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
32
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
Phase 1 Cohort 1:Ofatumumab
Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 2: Ofatumumab
Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
|
Phase1 Cohort 3
Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
|
Phase 2: Maximum Tolerated Dose of Ofatumumab
Phase II: Maximum tolerated dose (MTD) of Ofatumumab
Ofatumumab at 1000 mg on day 0 and 14
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
6
|
Baseline Characteristics
Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
Baseline characteristics by cohort
| Measure |
Phase 1 Cohort 1: Ofatumumab
n=3 Participants
Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 2: Ofatumumab
n=3 Participants
Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 3: Ofatumumab
n=6 Participants
Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
|
Phase 2: Maximum Tolerated Dose of Ofatumumab
n=32 Participants
Phase II: Maximum tolerated dose (MTD) of Ofatumumab
Ofatumumab at 1000 mg on day 0 and 14
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
32 participants
n=7 Participants
|
44 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: within 21 days of initiationPopulation: All participants in phase 1 portion of study
Maximum Tolerated Dose was determined by increasing doses, beginning at 300 mg on day 0 and day 14, then increasing to 700 mg on day 0 and day 14 and finally 1000 mg on day 0 and day 14.
Outcome measures
| Measure |
Phase 1: All Participants
n=12 Participants
All participants in phase 1 portion of study who received at least 1 dose of Ofatumumab either at 300 mg, 700 mg or 1000 mg.
|
|---|---|
|
Maximum Tolerated Dose of Ofatumumab
|
1000 mg
|
PRIMARY outcome
Timeframe: 6 months following initiation of OfatumumabPopulation: Participants enrolled in Phase 2 portion of study
Overall response rate (ORR) at 6 months following initiation of therapy. ORR is the composite outcome of complete response and partial response
Outcome measures
| Measure |
Phase 1: All Participants
n=32 Participants
All participants in phase 1 portion of study who received at least 1 dose of Ofatumumab either at 300 mg, 700 mg or 1000 mg.
|
|---|---|
|
Participants Response Rates
|
62.5 percentage of participants
Interval 44.0 to 79.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Participants enrolled in Phase 2 portion of study.
Overall Survival is defined as the time period from start of treatment to death.
Outcome measures
| Measure |
Phase 1: All Participants
n=32 Participants
All participants in phase 1 portion of study who received at least 1 dose of Ofatumumab either at 300 mg, 700 mg or 1000 mg.
|
|---|---|
|
Overall Survival (OS) at 24 Months
|
74.4 percentage of participants
Interval 56.6 to 85.8
|
Adverse Events
Phase 1 Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1 Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Cohort 3
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 2: MTD
Serious events: 25 serious events
Other events: 24 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1
n=3 participants at risk
Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 2
n=3 participants at risk
Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 3
n=6 participants at risk
Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
|
Phase 2: MTD
n=32 participants at risk
Phase II: Maximum tolerated dose (MTD) of Ofatumumab Ofatumumab at 1000 mg on day 0 and 14
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
3.1%
1/32 • Number of events 2 • 6 years, 6 months
|
|
Infections and infestations
Lung Infection
|
33.3%
1/3 • Number of events 2 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
9.4%
3/32 • Number of events 6 • 6 years, 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 2 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Investigations
Aspartate aminotrasnferase increased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 3 • 6 years, 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
2/6 • Number of events 2 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
2/6 • Number of events 2 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders -Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
2/6 • Number of events 2 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 2 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 3 • 6 years, 6 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
Other adverse events
| Measure |
Phase 1 Cohort 1
n=3 participants at risk
Phase I Cohort 1: dose of ofatumumab at 300 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 2
n=3 participants at risk
Phase I Cohort 2: dose of ofatumumab at 700 mg given on day 0 and 14 of study.
|
Phase 1 Cohort 3
n=6 participants at risk
Phase I Cohort 3: dose of ofatumumab at 1000 mg given on day 0 and 14 of study.
|
Phase 2: MTD
n=32 participants at risk
Phase II: Maximum tolerated dose (MTD) of Ofatumumab Ofatumumab at 1000 mg on day 0 and 14
|
|---|---|---|---|---|
|
Investigations
Neutrophil Count decreased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 2 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Infusion related reactions
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
33.3%
2/6 • Number of events 2 • 6 years, 6 months
|
25.0%
8/32 • Number of events 10 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Lower GI hemorrhage
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Upper GI hemorrhage
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
General disorders and administration site conditions -Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
12.5%
4/32 • Number of events 5 • 6 years, 6 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 6 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
9.4%
3/32 • Number of events 4 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 3 • 6 years, 6 months
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
33.3%
2/6 • Number of events 2 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 2 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Infections and infestations - Other
|
33.3%
1/3 • Number of events 3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 2 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
2/6 • Number of events 3 • 6 years, 6 months
|
12.5%
4/32 • Number of events 4 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Number of events 2 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders -Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
6.2%
2/32 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 6 years, 6 months
|
33.3%
1/3 • Number of events 1 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures -Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders -Other
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
16.7%
1/6 • Number of events 1 • 6 years, 6 months
|
0.00%
0/32 • 6 years, 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/3 • 6 years, 6 months
|
0.00%
0/6 • 6 years, 6 months
|
3.1%
1/32 • Number of events 1 • 6 years, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place