Trial Outcomes & Findings for Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer (NCT NCT02448303)
NCT ID: NCT02448303
Last Updated: 2019-09-12
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Every 12 weeks for up to 2 years
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Arm 1 - Pembrolizumab Monotherapy
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Arm 2 - Acalabrutinib + Pembrolizumab
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
Enrolled
|
38
|
36
|
|
Overall Study
Received Study Medication
|
33
|
35
|
|
Overall Study
Discontinued Study
|
38
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
38
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 - Pembrolizumab Monotherapy
n=33 Participants
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=35 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 9.33 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 9.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 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
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
35 participants
n=107 Participants
|
68 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 12 weeks for up to 2 yearsPopulation: The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed. And some of the participants didn't make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm 1 - Pembrolizumab Monotherapy
n=31 Participants
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=28 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Number of Participants With Overall Response
|
4 Participants
|
4 Participants
|
Adverse Events
Arm 1 - Pembrolizumab Monotherapy
Serious events: 12 serious events
Other events: 33 other events
Deaths: 18 deaths
Arm 2 - Acalabrutinib + Pembrolizumab
Serious events: 18 serious events
Other events: 35 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm 1 - Pembrolizumab Monotherapy
n=33 participants at risk
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=35 participants at risk
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Large Intestine Haemorrhage
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Asthenia
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pain
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Hepatobiliary disorders
Bile Duct Obstructions
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Oral Candidiasis
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Tremor
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Mental Status Changes
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Haematoma
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Orthostatic Hypotension
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
Other adverse events
| Measure |
Arm 1 - Pembrolizumab Monotherapy
n=33 participants at risk
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=35 participants at risk
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
5/33 • Safety Analysis tracked from 0 day to 2 years.
|
25.7%
9/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Ear and labyrinth disorders
Ear Pain
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Endocrine disorders
Hypothyroidism
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Eye disorders
Diplopia
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
21.2%
7/33 • Safety Analysis tracked from 0 day to 2 years.
|
31.4%
11/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33 • Safety Analysis tracked from 0 day to 2 years.
|
34.3%
12/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
37.1%
13/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
20.0%
7/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Fatigue
|
45.5%
15/33 • Safety Analysis tracked from 0 day to 2 years.
|
25.7%
9/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema Peripheral
|
15.2%
5/33 • Safety Analysis tracked from 0 day to 2 years.
|
20.0%
7/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pyrexia
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Asthenia
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Chest Pain
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Immune system disorders
Seasonal Allergy
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Oral Candidiasis
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Bronchitis
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Chills
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Mucosal Inflammation
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pain
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Weight Decreased
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Blood Creatinine Increased
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Electrocardiogram QT Prolonged
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Lymphocyte Count Decreased
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Amylase Increased
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Weight Increased
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
18.2%
6/33 • Safety Analysis tracked from 0 day to 2 years.
|
34.3%
12/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
6/33 • Safety Analysis tracked from 0 day to 2 years.
|
17.1%
6/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.1%
4/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
20.0%
7/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Dizziness
|
12.1%
4/33 • Safety Analysis tracked from 0 day to 2 years.
|
20.0%
7/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Headache
|
18.2%
6/33 • Safety Analysis tracked from 0 day to 2 years.
|
17.1%
6/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Neuropathy Peripheral
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Somnolence
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Depression
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Confusional State
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.2%
8/33 • Safety Analysis tracked from 0 day to 2 years.
|
31.4%
11/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
6/33 • Safety Analysis tracked from 0 day to 2 years.
|
28.6%
10/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.2%
5/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
12.1%
4/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
9.1%
3/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.2%
5/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rash Maculo-Papular
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Decubitus Ulcer
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Petechiae
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
14.3%
5/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hot Flush
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
2.9%
1/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
2/33 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
11.4%
4/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
3.0%
1/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
8.6%
3/35 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/33 • Safety Analysis tracked from 0 day to 2 years.
|
5.7%
2/35 • Safety Analysis tracked from 0 day to 2 years.
|
Additional Information
Priti Patel, MD, Executive Director - Head of Clinical Development
Acerta Pharma, LLC
Phone: 1-888-292-9613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place