Trial Outcomes & Findings for A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma (NCT NCT01882803)
NCT ID: NCT01882803
Last Updated: 2023-09-07
Results Overview
ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Every 8-16 weeks while on treatment with duvelisib for up to 72 months
Results posted on
2023-09-07
Participant Flow
This multicenter, multinational study enrolled participants at 56 medical clinics across 12 countries.
Participant milestones
| Measure |
Duvelisib
Participants received a dose of 25 milligrams (mg) duvelisib twice daily (BID) over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
129
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
129
|
Reasons for withdrawal
| Measure |
Duvelisib
Participants received a dose of 25 milligrams (mg) duvelisib twice daily (BID) over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Death
|
68
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Follow-up Completed
|
39
|
|
Overall Study
Study Terminated by the Sponsor
|
6
|
Baseline Characteristics
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=5 Participants
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 8-16 weeks while on treatment with duvelisib for up to 72 monthsPopulation: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.
Outcome measures
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
59.7 percentage of participants
Interval 50.7 to 68.2
|
—
|
SECONDARY outcome
Timeframe: Every 2-8 weeks for up to 73 monthsPopulation: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. 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=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
128 Participants
|
—
|
SECONDARY outcome
Timeframe: Every 8-16 weeks for up to 72 monthsPopulation: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Duration of Response (DOR)
|
10.16 months
Interval 8.78 to 13.61
|
—
|
SECONDARY outcome
Timeframe: Every 8-16 weeks for up to 72 monthsPopulation: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
PFS, 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, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
9.57 months
Interval 8.35 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Every 16 weeks for up to 72 monthsPopulation: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Overall Survival (OS)
|
28.96 months
Interval 21.37 to 37.02
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit)Population: Pharmacokinetics (PK) Set: all participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample.
The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Duvelisib
n=129 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
n=129 Participants
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Plasma Concentration of Duvelisib and IPI-656
C1D15 Predose
|
414 ng/mL
Interval 19.0 to 4590.0
|
648 ng/mL
Interval 116.0 to 6010.0
|
|
Plasma Concentration of Duvelisib and IPI-656
C1D15 1 hour post dose
|
1175 ng/mL
Interval 206.0 to 6820.0
|
641 ng/mL
Interval 160.0 to 5920.0
|
|
Plasma Concentration of Duvelisib and IPI-656
C1D15 4 hours post dose
|
852 ng/mL
Interval 233.0 to 5170.0
|
714 ng/mL
Interval 230.0 to 6020.0
|
|
Plasma Concentration of Duvelisib and IPI-656
C2D1
|
631 ng/mL
Interval to 4180.0
\<lower limit of quantification
|
704 ng/mL
Interval to 10200.0
\<lower limit of quantification
|
|
Plasma Concentration of Duvelisib and IPI-656
C3D1
|
696 ng/mL
Interval to 3540.0
\<lower limit of quantification
|
664 ng/mL
Interval to 6850.0
\<lower limit of quantification
|
SECONDARY outcome
Timeframe: First dose to first documentation of complete or partial response (up to 6 months)Population: Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib and who were considered responders (CR or PR) per IRC.
TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee \[IRC\]) according to the revised IWG Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
Duvelisib
n=59 Participants
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
IPI-656
Participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample for measuring concentrations of the main duvelisib metabolite, IPI-656.
|
|---|---|---|
|
Time to Response (TTR)
|
1.87 month
Interval 1.71 to 3.65
|
—
|
Adverse Events
Duvelisib
Serious events: 83 serious events
Other events: 122 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
Duvelisib
n=129 participants at risk
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
9/129 • 73 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
4/129 • 73 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/129 • 73 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
2/129 • 73 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.78%
1/129 • 73 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
2/129 • 73 months
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/129 • 73 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
1/129 • 73 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.78%
1/129 • 73 months
|
|
Cardiac disorders
Pericarditis
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
10/129 • 73 months
|
|
Gastrointestinal disorders
Colitis
|
4.7%
6/129 • 73 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/129 • 73 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.6%
2/129 • 73 months
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/129 • 73 months
|
|
Gastrointestinal disorders
Abdominal mass
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Duodenitis
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.78%
1/129 • 73 months
|
|
General disorders
Disease progression
|
7.0%
9/129 • 73 months
|
|
General disorders
Pyrexia
|
3.1%
4/129 • 73 months
|
|
General disorders
Fatigue
|
0.78%
1/129 • 73 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.78%
1/129 • 73 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pneumonia
|
5.4%
7/129 • 73 months
|
|
Infections and infestations
Bronchopneumonia
|
3.1%
4/129 • 73 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Cellulitis
|
2.3%
3/129 • 73 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Cystitis pseudomonal
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Diverticulitis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Escherichia sepsis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Gastroenteritis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Infective myositis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Influenza
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Klebsiella sepsis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
2/129 • 73 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Oral candidiasis
|
1.6%
2/129 • 73 months
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
1.6%
2/129 • 73 months
|
|
Infections and infestations
Pseudomembranous colitis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pseudomonal sepsis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Scrotal infection
|
1.1%
1/88 • 73 months
|
|
Infections and infestations
Sepsis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Sepsis syndrome
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Septic shock
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Viral infection
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Vulval cellulitis
|
2.4%
1/41 • 73 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.78%
1/129 • 73 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.78%
1/129 • 73 months
|
|
Investigations
Alanine aminotransferase increased
|
0.78%
1/129 • 73 months
|
|
Investigations
Blood creatinine increased
|
0.78%
1/129 • 73 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
2/129 • 73 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
2/129 • 73 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.78%
1/129 • 73 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.78%
1/129 • 73 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.78%
1/129 • 73 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.3%
3/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.78%
1/129 • 73 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/129 • 73 months
|
|
Renal and urinary disorders
Renal failure acute
|
3.1%
4/129 • 73 months
|
|
Renal and urinary disorders
Renal failure
|
1.6%
2/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
3/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
4/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.78%
1/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
3/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.6%
2/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.78%
1/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.78%
1/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.78%
1/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.78%
1/129 • 73 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.78%
1/129 • 73 months
|
|
Vascular disorders
Embolism
|
0.78%
1/129 • 73 months
|
|
Vascular disorders
Peripheral embolism
|
0.78%
1/129 • 73 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.78%
1/129 • 73 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
1/129 • 73 months
|
|
Eye disorders
Glaucoma
|
0.78%
1/129 • 73 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.78%
1/129 • 73 months
|
|
General disorders
General physical health deterioration
|
1.6%
2/129 • 73 months
|
|
Infections and infestations
Bronchitis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Campylobacter infection
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Enteritis infectious
|
0.78%
1/129 • 73 months
|
|
Infections and infestations
Pneumonia moraxella
|
0.78%
1/129 • 73 months
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.78%
1/129 • 73 months
|
|
Investigations
Amylase increased
|
0.78%
1/129 • 73 months
|
|
Investigations
Lipase increased
|
0.78%
1/129 • 73 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.78%
1/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
2/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
1/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/129 • 73 months
|
Other adverse events
| Measure |
Duvelisib
n=129 participants at risk
Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
28.7%
37/129 • 73 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.4%
25/129 • 73 months
|
|
Blood and lymphatic system disorders
Anaemia
|
27.9%
36/129 • 73 months
|
|
Gastrointestinal disorders
Diarrhoea
|
48.8%
63/129 • 73 months
|
|
Gastrointestinal disorders
Nausea
|
29.5%
38/129 • 73 months
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
22/129 • 73 months
|
|
Gastrointestinal disorders
Abdominal pain
|
15.5%
20/129 • 73 months
|
|
Gastrointestinal disorders
Constipation
|
11.6%
15/129 • 73 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
9/129 • 73 months
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
9/129 • 73 months
|
|
General disorders
Fatigue
|
28.7%
37/129 • 73 months
|
|
General disorders
Pyrexia
|
24.8%
32/129 • 73 months
|
|
General disorders
Oedema peripheral
|
17.1%
22/129 • 73 months
|
|
General disorders
Asthenia
|
11.6%
15/129 • 73 months
|
|
General disorders
Chills
|
7.0%
9/129 • 73 months
|
|
Infections and infestations
Oral Candidiasis
|
6.2%
8/129 • 73 months
|
|
Investigations
Alanine aminotransferase increased
|
13.2%
17/129 • 73 months
|
|
Investigations
Aspartate aminotransferase increased
|
10.1%
13/129 • 73 months
|
|
Investigations
Lipase increased
|
9.3%
12/129 • 73 months
|
|
Investigations
Weight decreased
|
10.1%
13/129 • 73 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.4%
7/129 • 73 months
|
|
Investigations
Blood creatinine increased
|
6.2%
8/129 • 73 months
|
|
Investigations
Neutrophil count decreased
|
5.4%
7/129 • 73 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.7%
19/129 • 73 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.0%
18/129 • 73 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
8/129 • 73 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.5%
11/129 • 73 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
18/129 • 73 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
19/129 • 73 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
13/129 • 73 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
8/129 • 73 months
|
|
Nervous system disorders
Headache
|
16.3%
21/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.1%
35/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.9%
14/129 • 73 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
8/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.1%
22/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.1%
13/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
10/129 • 73 months
|
|
Infections and infestations
Urinary tract infection
|
5.4%
7/129 • 73 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.4%
7/129 • 73 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.4%
7/129 • 73 months
|
|
Vascular disorders
Hypertension
|
5.4%
7/129 • 73 months
|
|
Vascular disorders
Hypotension
|
5.4%
7/129 • 73 months
|
|
Nervous system disorders
Dizziness
|
5.4%
7/129 • 73 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place