Trial Outcomes & Findings for A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07 (NCT NCT02049515)
NCT ID: NCT02049515
Last Updated: 2023-09-21
Results Overview
ORR was defined as the percentage of participants with a best response (per investigator assessment) of complete response (CR), CR with incomplete marrow recovery (CRi), partial response (PR), or PR with lymphocytosis (PRwL), according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) or revised International Working Group Response (IWG) Criteria, with modification for treatment-related lymphocytosis. The 95% confidence interval was calculated using exact binomial method. Select IWCLL criteria for tumor load assessed by computed tomography (CT): CR/CRi (CLL only), lymphadenopathy (none \>1.5 centimeters \[cm\]), hepatomegaly/splenomegaly (none); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%). Select IWG criteria for tumor load assessed by CT: CR, lymphadenopathy/hepatomegaly/splenomegaly (normal size); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
Until progressive disease (PD), death, or other anticancer therapy is initiated (up to 4.5 years)
Results posted on
2023-09-21
Participant Flow
All participants previously enrolled in study IPI-145-07 (NCT02004522) who experienced radiologically confirmed disease progression while on treatment in that study were eligible to participate in this study.
Participant milestones
| Measure |
IPI-145
IPI-145 was administered orally and supplied as 5 milligram (mg) and 25 mg formulated capsules.
|
Ofatumumab
Ofatumumab was administered as an intravenous (IV) infusion and was supplied in single-use vials at two strengths, 100 mg/5 milliliters (mL) and 1000 mg/50 mL.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
9
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
90
|
9
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
90
|
6
|
Reasons for withdrawal
| Measure |
IPI-145
IPI-145 was administered orally and supplied as 5 milligram (mg) and 25 mg formulated capsules.
|
Ofatumumab
Ofatumumab was administered as an intravenous (IV) infusion and was supplied in single-use vials at two strengths, 100 mg/5 milliliters (mL) and 1000 mg/50 mL.
|
|---|---|---|
|
Overall Study
Adverse Event
|
46
|
2
|
|
Overall Study
Protocol-specified Disease Progression
|
23
|
2
|
|
Overall Study
Death
|
6
|
0
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Termination of the Study by Sponsor
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Clinical Deterioration
|
1
|
0
|
|
Overall Study
Need Treatment for Metastatic Melanoma
|
1
|
0
|
|
Overall Study
Treatment Interruption >42 Days
|
1
|
0
|
|
Overall Study
Suspected and Unconfirmed Disease Progression
|
1
|
0
|
Baseline Characteristics
A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07
Baseline characteristics by cohort
| Measure |
IPI-145
n=90 Participants
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
n=9 Participants
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Until progressive disease (PD), death, or other anticancer therapy is initiated (up to 4.5 years)Population: All-treated analysis set: all participants who received any amount of study drug (IPI-145 or ofatumumab).
ORR was defined as the percentage of participants with a best response (per investigator assessment) of complete response (CR), CR with incomplete marrow recovery (CRi), partial response (PR), or PR with lymphocytosis (PRwL), according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) or revised International Working Group Response (IWG) Criteria, with modification for treatment-related lymphocytosis. The 95% confidence interval was calculated using exact binomial method. Select IWCLL criteria for tumor load assessed by computed tomography (CT): CR/CRi (CLL only), lymphadenopathy (none \>1.5 centimeters \[cm\]), hepatomegaly/splenomegaly (none); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%). Select IWG criteria for tumor load assessed by CT: CR, lymphadenopathy/hepatomegaly/splenomegaly (normal size); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%).
Outcome measures
| Measure |
IPI-145
n=90 Participants
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
n=9 Participants
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
76.7 percentage of participants
Interval 66.6 to 84.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the first documentation of response to the first documentation of PD or death due to any cause (up to 4.5 years)Population: All-treated analysis set: all participants who received any amount of study drug (IPI-145 or ofatumumab). DOR was evaluated using the Kaplan-Meier method based on all treated participants with documentation of response.
DOR was defined as the time from the first documentation of response per investigator assessment to either PD or death due to any cause. DOR was evaluated using the Kaplan-Meier method based on all treated participants with a documentation of response (that is, CR, CRi, PR, or PRwL) as determined by investigator assessment. Select IWCLL criteria for tumor load assessed by CT: CR/CRi (CLL only), lymphadenopathy (none \>1.5 cm), hepatomegaly/splenomegaly (none); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%). Select IWG criteria for tumor load assessed by CT: CR, lymphadenopathy/hepatomegaly/splenomegaly (normal size); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%).
Outcome measures
| Measure |
IPI-145
n=90 Participants
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
|---|---|---|
|
Duration of Response (DOR)
|
14.9 months
Interval 8.55 to 18.6
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study treatment to the first documentation of PD or death from any cause (up to 4.5 years)Population: All-treated analysis set: all participants who received any amount of study drug (IPI-145 or ofatumumab). PFS was determined using the Kaplan-Meier method based on all treated participants with documentation of response.
PFS was defined as the time from the first dose of study treatment to the first documentation of either investigator-assessed PD or death resulting from any cause. PFS was determined using the Kaplan-Meier method based on all treated participants with a documentation of response (that is, CR, CRi, PR, or PRwL) as determined by investigator assessment.
Outcome measures
| Measure |
IPI-145
n=90 Participants
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
15.3 months
Interval 12.2 to 20.6
|
—
|
Adverse Events
IPI-145
Serious events: 68 serious events
Other events: 80 other events
Deaths: 20 deaths
Ofatumumab
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IPI-145
n=90 participants at risk
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
n=9 participants at risk
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
3/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Cardiac disorders
Atrioventricular block complete
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Cardiac disorders
Cardiac failure chronic
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Endocrine disorders
Hypopituitarism
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
17.8%
16/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Colitis
|
8.9%
8/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Pyrexia
|
3.3%
3/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Disease progression
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
General physical health deterioration
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Drug intolerance
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Multi-organ failure
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
3.3%
3/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pseudomonal sepsis
|
3.3%
3/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Bronchitis
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Campylobacter gastroenteritis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Campylobacter infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Device related infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
H1N1 influenza
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Influenza
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Laryngitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Lung infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Mucosal infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumonia haemophilus
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Salmonellosis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Staphylococcal skin infection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Urosepsis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Sepsis
|
4.4%
4/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Pneumonia
|
14.4%
13/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Investigations
Transaminases increased
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Cerebral ischaemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Dizziness
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Encephalitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Mental impairment
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Muscle contractions involuntary
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Renal and urinary disorders
Azotaemia
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Renal and urinary disorders
Renal failure acute
|
4.4%
4/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
2/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Pityriasis lichenoides et varioliformis acuta
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Pityriasis rubra pilaris
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Vascular disorders
Aortic dissection
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Vascular disorders
Arterial rupture
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Vascular disorders
Vena cava thrombosis
|
1.1%
1/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Oedema
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
Other adverse events
| Measure |
IPI-145
n=90 participants at risk
IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
|
Ofatumumab
n=9 participants at risk
Ofatumumab was administered as an IV infusion and was supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
25.6%
23/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
9/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
8/90 • 4.5 years
|
22.2%
2/9 • 4.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
47.8%
43/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
10/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
9/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Nausea
|
11.1%
10/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
7/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
5/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Pyrexia
|
23.3%
21/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Asthenia
|
12.2%
11/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
General disorders
Oedema peripheral
|
6.7%
6/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Bronchitis
|
8.9%
8/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
7/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Respiratory tract infection
|
5.6%
5/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Infections and infestations
Urinary tract infection
|
6.7%
6/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Investigations
Lipase increased
|
10.0%
9/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.2%
11/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
7/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
9/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Nervous system disorders
Headache
|
7.8%
7/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
15/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
21/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
2/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
3/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
1.1%
1/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Infections and infestations
Fungal infection
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/90 • 4.5 years
|
33.3%
3/9 • 4.5 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.2%
2/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
5/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/33 • 4.5 years
|
25.0%
1/4 • 4.5 years
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/33 • 4.5 years
|
25.0%
1/4 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
3/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.3%
3/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Vascular disorders
Hypertension
|
2.2%
2/90 • 4.5 years
|
11.1%
1/9 • 4.5 years
|
|
Gastrointestinal disorders
Colitis
|
6.7%
6/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
5/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
|
Investigations
Weight decreased
|
7.8%
7/90 • 4.5 years
|
0.00%
0/9 • 4.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place