Trial Outcomes & Findings for Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma (NCT NCT02454179)
NCT ID: NCT02454179
Last Updated: 2019-09-12
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
78 participants
Primary outcome timeframe
52 weeks
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Mono Therapy of Pembrolizumab Arm 1
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Combo Therapy Acalabrutinib + Pembrolizumab Arm 2
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
Enrolled
|
39
|
39
|
|
Overall Study
Received Study Medication
|
39
|
37
|
|
Overall Study
Discontinue Study
|
39
|
39
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Mono Therapy Arm - Pembrolizumab
n=39 Participants
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Combo Therapy Arm - Acalabrutinib + Pembrolizumab
n=37 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 10.45 • n=99 Participants
|
61.4 Years
STANDARD_DEVIATION 11.12 • n=107 Participants
|
61.8 Years
STANDARD_DEVIATION 10.71 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 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
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
66 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: 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 v1.0) 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 |
Mono Therapy Arm - Pembrolizumab
n=37 Participants
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Combo Therapy Arm - Acalabrutinib and Pembrolizumab
n=30 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Number of Participants With Overall Response
|
7 Participants
|
5 Participants
|
Adverse Events
Arm 1 - Pembrolizumab
Serious events: 12 serious events
Other events: 39 other events
Deaths: 26 deaths
Arm 2 - Acalabrutinib + Pembrolizumab
Serious events: 25 serious events
Other events: 37 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm 1 - Pembrolizumab
n=39 participants at risk
Pembrolizumab Monotherapy
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=37 participants at risk
Acalabrutinib in combination with Pembrolizumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Atrial Flutter
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Mouth Heamorrhage
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Chest Pain
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Clostridia Sepsis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Epiglottistis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Stoma Site Haemorrhage
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Heaorrhage
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypnoxia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Embolism
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Orthrostatic Hypotension
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
Other adverse events
| Measure |
Arm 1 - Pembrolizumab
n=39 participants at risk
Pembrolizumab Monotherapy
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=37 participants at risk
Acalabrutinib in combination with Pembrolizumab
|
|---|---|---|
|
General disorders
Mucosal Inflammation
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Immune system disorders
Seasonal Allergy
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
13.5%
5/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Candida Infection
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Cellulitis
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Urinary Tract Infection
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Aptyalism
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Fatigue
|
51.3%
20/39 • Safety Analysis tracked from 0 day to 2 years.
|
37.8%
14/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema Peripheral
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
24.3%
9/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pyrexia
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
21.6%
8/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Asthenia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
18.9%
7/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Chills
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
18.9%
7/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Oral Pain
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
32.4%
12/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Tachycardia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Endocrine disorders
Hypothyroidism
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
24.3%
9/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
29.7%
11/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
21.6%
8/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
White Blood Cell Count Decreased
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
29.7%
11/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
27.0%
10/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Oral Candidiasis
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Weight Decreased
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
24.3%
9/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Blood Creatinine Increased
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Platelet Count Decreased
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletel Pain
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Headache
|
20.5%
8/39 • Safety Analysis tracked from 0 day to 2 years.
|
18.9%
7/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Speech Disorder
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Syncope
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
21.6%
8/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Eating Disorder
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Nocturia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
29.7%
11/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
8/39 • Safety Analysis tracked from 0 day to 2 years.
|
18.9%
7/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
13.5%
5/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hypotension
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
2.7%
1/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
16.2%
6/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
10.8%
4/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
8.1%
3/37 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
5.4%
2/37 • 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