Trial Outcomes & Findings for Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (NCT NCT02112526)
NCT ID: NCT02112526
Last Updated: 2024-12-20
Results Overview
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Relapse Subjects
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
Cohort 2 - Refractory Subjects
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
Enrolled
|
11
|
10
|
|
Overall Study
Received Study Medication
|
11
|
10
|
|
Overall Study
Discontinued Study
|
11
|
9
|
|
Overall Study
Subjects Continuing Study Medication
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1 - Relapse Subjects
n=11 Participants
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
Cohort 2 - Refractory Subjects
n=10 Participants
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 Year
STANDARD_DEVIATION 9.57 • n=5 Participants
|
56.9 Year
STANDARD_DEVIATION 16.26 • n=7 Participants
|
64.1 Year
STANDARD_DEVIATION 14.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Outcome measures
| Measure |
Cohort 1 - Relapse Subjects
n=11 Participants
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
Cohort 2 - Refractory Subjects
n=10 Participants
Acalabrutinib 100mg administered orally (PO) twice daily (BID)
|
|---|---|---|
|
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 Cycle (28 days)To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 Cycle (28 days)To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 Cycles (1 cycle = 28 days) and at end of treatmentTo evaluate the concentration pharmacodynamic effects of acalabrutinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)To evaluate the activity of acalabrutinib as measured by ORR
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 - Relapse Subjects
Serious events: 4 serious events
Other events: 10 other events
Deaths: 3 deaths
Cohort 2 - Refractory Subjects
Serious events: 5 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1 - Relapse Subjects
n=11 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily
|
Cohort 2 - Refractory Subjects
n=10 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Disease progression
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Fatigue
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Septic shock
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Viral infection
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Investigations
Influenza B virus test positive
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
Other adverse events
| Measure |
Cohort 1 - Relapse Subjects
n=11 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily
|
Cohort 2 - Refractory Subjects
n=10 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
40.0%
4/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Cardiac disorders
Mitral valve incompetence
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Endocrine disorders
Adrenal insufficiency
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Eye disorders
Conjunctival hyperaemia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Eye disorders
Dry eye
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Eye disorders
Ocular hyperaemia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Diarrhoea
|
72.7%
8/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
30.0%
3/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Faeces discoloured
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Fatigue
|
36.4%
4/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
40.0%
4/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Oedema peripheral
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Gait disturbance
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Pyrexia
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Axillary pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Chills
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Injection site bruising
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Injection site rash
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Mucosal inflammation
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Oedema
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Hepatobiliary disorders
Cholecystitis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Immune system disorders
Contrast media allergy
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Oral candidiasis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Oral herpes
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Rhinovirus infection
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Staphylococcal infection
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Injury, poisoning and procedural complications
Contusion
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Investigations
Breath sounds abnormal
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Investigations
C-reactive protein increased
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Investigations
Cardiac murmur
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Investigations
Weight decreased
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Dizziness
|
45.5%
5/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Carpal tunnel syndrome
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Psychiatric disorders
Mental status changes
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Renal and urinary disorders
Urinary retention disorders
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
30.0%
3/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
20.0%
2/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
10.0%
1/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
1/11 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
0.00%
0/10 • Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 697
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place