Trial Outcomes & Findings for TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL) (NCT NCT04163718)
NCT ID: NCT04163718
Last Updated: 2026-01-06
Results Overview
Overall Response Rate (ORR) of Umbralisib Treatment will be determined according to the criteria of the International Workshop on Chronic Lymphocytic Leukemia. ORR is defined as the percent of participants who achieve Complete Response (CR) or Partial Response (PR). Due to early study termination, result data is provided as best response at End of Treatment/Study Termination.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Treatment With Umbralisib
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Treatment With Umbralisib
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Overall Study
Study terminated
|
12
|
Baseline Characteristics
TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Treatment With Umbralisib
n=12 Participants
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Evaluable participants
Overall Response Rate (ORR) of Umbralisib Treatment will be determined according to the criteria of the International Workshop on Chronic Lymphocytic Leukemia. ORR is defined as the percent of participants who achieve Complete Response (CR) or Partial Response (PR). Due to early study termination, result data is provided as best response at End of Treatment/Study Termination.
Outcome measures
| Measure |
Treatment With Umbralisib
n=9 Participants
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Overall Response Rate (Complete Response and Partial Response)
Stable Disease
|
1 Participants
|
|
Overall Response Rate (Complete Response and Partial Response)
Partial Response
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: PFS cannot be calculated. Drug was withdrawn by FDA, therefore all participants off treatment too early to determine survival.
Progression Free Survival (PFS) is defined as the interval from registration to the earlier of the first documentation of definitive disease progression or death from any cause.
Outcome measures
| Measure |
Treatment With Umbralisib
n=9 Participants
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Progression Free Survival (PFS)
|
NA participants
Insufficient number of participants with events because drug was withdrawn by FDA, therefore all participants off treatment too early
|
SECONDARY outcome
Timeframe: Up to 15 monthsNumber of participants with adverse events after receiving one dose of Umbralisib..
Outcome measures
| Measure |
Treatment With Umbralisib
n=12 Participants
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
10 participants
|
Adverse Events
Treatment With Umbralisib
Serious events: 10 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment With Umbralisib
n=12 participants at risk
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Esophageal perforation
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Fever
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Death, NOS
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 pneumonia
|
33.3%
4/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Cardiac disorders
Cardiac disorders -Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
General disorders and administration site conditions -Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
Other adverse events
| Measure |
Treatment With Umbralisib
n=12 participants at risk
Umbralisib: 800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
|
|---|---|
|
General disorders
Gait disturbance
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
General disorders and administration site conditions - Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Localized edema
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
4/12 • Number of events 5 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
6/12 • Number of events 8 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
33.3%
4/12 • Number of events 5 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other,
|
41.7%
5/12 • Number of events 6 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
3/12 • Number of events 9 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Infections and infestations - Other
|
25.0%
3/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Eye infection
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Tooth infection
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Infections and infestations
Wound infection
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Psychiatric disorders
Confusion
|
25.0%
3/12 • Number of events 5 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Psychiatric disorders
Hallucinations
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
8.3%
1/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Vascular disorders
Flushing
|
16.7%
2/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Renal and urinary disorders
Urinary urgency
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Eye disorders
Eye pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Reproductive system and breast disorders
Breast pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • Number of events 5 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Weight loss
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
1/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
4/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Concentration impairment
|
16.7%
2/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Paresthesia
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Tremor
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Akathisia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Hypersomnia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Nervous system disorders - Other
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Pain
|
41.7%
5/12 • Number of events 8 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Fever
|
25.0%
3/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Edema limbs
|
16.7%
2/12 • Number of events 4 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Malaise
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • Number of events 10 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Diarrhea
|
58.3%
7/12 • Number of events 13 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Belching
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Esophageal perforation
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Stomach pain
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Neutrophil count decreased
|
50.0%
6/12 • Number of events 15 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
3/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
|
Investigations
Creatinine increased
|
25.0%
3/12 • Number of events 3 • Adverse events collected from on treatment date through off study date, an average of 15 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place