Trial Outcomes & Findings for Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191) (NCT NCT02537444)
NCT ID: NCT02537444
Last Updated: 2019-09-25
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
78 participants
Primary outcome timeframe
Every 12 weeks for up to 2 years.
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
Arm 1 - Acalabrutinib Monotherapy
Acalabrutinib 100mg administered orally (PO) twice daily BID.
|
Arm 2 - Acalabrutinib + Pembrolizumab
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
|
38
|
39
|
|
Overall Study
Discontinued Study
|
39
|
39
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
Baseline characteristics by cohort
| Measure |
Arm 1 - Acalabrutinib Monotherapy
n=38 Participants
Acalabrutinib 100mg administered orally (PO) twice daily BID.
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=39 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 12.75 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
39 participants
n=7 Participants
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 12 weeks for up to 2 years.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 - Acalabrutinib Monotherapy
n=35 Participants
Acalabrutinib 100mg administered orally (PO) twice daily.
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=33 Participants
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Number of Participants With Overall Response
|
1 Participants
|
3 Participants
|
Adverse Events
Arm 1 - Acalabrutinib Monotherapy
Serious events: 8 serious events
Other events: 34 other events
Deaths: 16 deaths
Arm 2 - Acalabrutinib + Pembrolizumab
Serious events: 16 serious events
Other events: 39 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Arm 1 - Acalabrutinib Monotherapy
n=38 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily (BID).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=39 participants at risk
Acalabrutinib 100mg plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Pericardial Effusion
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Embolism
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
Other adverse events
| Measure |
Arm 1 - Acalabrutinib Monotherapy
n=38 participants at risk
Acalabrutinib 100mg administered orally (PO) twice daily (BID).
|
Arm 2 - Acalabrutinib + Pembrolizumab
n=39 participants at risk
Acalabrutinib 100mg plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
30.8%
12/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Cardiac disorders
Tachycardia
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Eye disorders
Vision Blurred
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
42.1%
16/38 • Safety Analysis tracked from 0 day to 2 years.
|
74.4%
29/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
44.7%
17/38 • Safety Analysis tracked from 0 day to 2 years.
|
28.2%
11/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
7/38 • Safety Analysis tracked from 0 day to 2 years.
|
53.8%
21/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.7%
9/38 • Safety Analysis tracked from 0 day to 2 years.
|
35.9%
14/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Distension
|
18.4%
7/38 • Safety Analysis tracked from 0 day to 2 years.
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
20.5%
8/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.5%
4/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Ascites
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Fatigue
|
42.1%
16/38 • Safety Analysis tracked from 0 day to 2 years.
|
51.3%
20/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Oedema Peripheral
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Chills
|
10.5%
4/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Pain
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Urinary Tract Infection
|
13.2%
5/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
21.1%
8/38 • Safety Analysis tracked from 0 day to 2 years.
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
10.5%
4/38 • Safety Analysis tracked from 0 day to 2 years.
|
25.6%
10/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.5%
4/38 • Safety Analysis tracked from 0 day to 2 years.
|
23.1%
9/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Blood Creatinine Increased
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Weight Decreased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Lymphocyte Count Decreased
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Protein Total Decreased
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Investigations
Carbohydrate Antigen 125 Increased
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
23.7%
9/38 • Safety Analysis tracked from 0 day to 2 years.
|
25.6%
10/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletel Pain
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Headache
|
44.7%
17/38 • Safety Analysis tracked from 0 day to 2 years.
|
53.8%
21/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Psychiatric disorders
Depression
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
2.6%
1/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Reproductive system and breast disorders
Vaginal Haematuria
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
25.6%
10/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.2%
5/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
17.9%
7/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
12.8%
5/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
0.00%
0/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Vascular disorders
Hot Flush
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
7.7%
3/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Nervous system disorders
Dizziness
|
23.7%
9/38 • Safety Analysis tracked from 0 day to 2 years.
|
23.1%
9/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
23.1%
9/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
3/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/38 • Safety Analysis tracked from 0 day to 2 years.
|
15.4%
6/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/38 • Safety Analysis tracked from 0 day to 2 years.
|
10.3%
4/39 • Safety Analysis tracked from 0 day to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.3%
2/38 • Safety Analysis tracked from 0 day to 2 years.
|
5.1%
2/39 • 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