Trial Outcomes & Findings for A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145) (NCT NCT02711852)
NCT ID: NCT02711852
Last Updated: 2023-09-11
Results Overview
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 45 months
Results posted on
2023-09-11
Participant Flow
A total of 19 participants were enrolled in the current study from 3 previous studies: IPI-145-01(NCT01549106), IPI-145-02 (NCT01476657), and IPI-145-08 (NCT02204982).
Participant milestones
| Measure |
Duvelisib
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
19
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Duvelisib
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Completed follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Baseline characteristics by cohort
| Measure |
Duvelisib
n=19 Participants
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 45 monthsPopulation: All Treated Analysis Set included all participants who received at least one dose of duvelisib.
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Duvelisib
n=19 Participants
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 45 monthsPopulation: All Treated Analysis Set included all participants who received at least one dose of duvelisib and for whom a documented response was available.
There were no formal secondary endpoints planned and captured data was based on disease response assessment and overall survival (OS) as defined in the participant's previous study. BOR was defined as the best time point response that a participant achieves during the study, with the response ranked according to the following order (from best to worst): complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), stable disease (SD).
Outcome measures
| Measure |
Duvelisib
n=16 Participants
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
CR/CRi
|
9 Participants
|
|
Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
PR
|
5 Participants
|
|
Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
SD
|
1 Participants
|
|
Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
Response not evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 45 monthsPopulation: All Treated Analysis Set included all participants who received at least one dose of duvelisib.
No formal secondary endpoints were planned for this study. OS was monitored in participants who continued to receive duvelisib treatment and/or in the long-term survival follow-up period in a previous duvelisib study and the number of participants alive at end of study were reported. Participants being followed for OS were contacted by the study site approximately every 6 months to collect survival status and data pertaining to any other alternative antineoplastic therapy.
Outcome measures
| Measure |
Duvelisib
n=19 Participants
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Overall Survival (OS)
|
14 Participants
|
Adverse Events
Duvelisib
Serious events: 5 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Duvelisib
n=19 participants at risk
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Enteritis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Pneumonia viral
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Pseudomonal sepsis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
Other adverse events
| Measure |
Duvelisib
n=19 participants at risk
Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.1%
4/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Eye disorders
Glaucoma
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
5/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Haematochezia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Gastrointestinal disorders
Reflux gastritis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Fatigue
|
21.1%
4/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Influenza like illness
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Brucellosis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Candida infection
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Conjunctivitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Influenza
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Respiratory tract infection
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Tooth abscess
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.1%
4/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Investigations
Blood triglycerides increased
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Investigations
Lipase increased
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
3/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Vascular disorders
Thrombophlebitis superficial
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
5.3%
1/19 • Up to 45 months
All Treated Analysis Set included all participants who received at least one dose of duvelisib. All-cause mortality, serious adverse event, and other adverse event data were pre-specified to be collected as a single arm for any participant who received at least one dose of the study drug, regardless of their dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place