Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
Study Details
Study Description
Brief Summary
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm A Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily. |
Drug: Acalabrutinib (Arm A)
A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
Other Names:
Drug: Acalabrutinib (Arm B)
B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;
• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.
Other Names:
|
Experimental: Arm B Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily. |
Drug: Acalabrutinib (Arm A)
A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
Other Names:
Drug: Acalabrutinib (Arm B)
B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;
• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Response Based on Overall Response Rate [Cycle 1 (28 Days) to 6 months]
The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women 18 years of age and older with histologically confirmed disease.
-
Active disease as defined by at least one of the following (IWCLL consensus criteria):
-
Weight loss ≥10% within the previous 6 months
-
Extreme fatigue
-
Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection
-
Night sweats for more than one month without evidence of infection
-
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
-
Massive or progressive splenomegaly
-
Massive nodes or clusters or progressive lymphadenopathy
-
Progressive lymphocytosis with an increase of >50% over a 2 month period, or an anticipated doubling time of less than 6 months
-
Compensated autoimmune hemolysis
-
Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation
-
Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children.
-
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies.
-
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Exclusion Criteria:
-
Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks.
-
Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- Acerta Pharma BV
- National Institutes of Health (NIH)
Investigators
- Study Director: AstraZeneca Clinical Study Information Center, 1-877-240-9479 - information.center@astrazeneca.com
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 15-H-0016
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive |
---|---|---|---|---|
Arm/Group Description | relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day | Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day | Treatment naive subjects treated with acalabrutinib 100 mg twice a day | Treatment naive subjects treated with acalabrutinib 200 mg once a day |
Period Title: Overall Study | ||||
STARTED | 18 | 14 | 6 | 10 |
COMPLETED | 0 | 0 | 0 | 0 |
NOT COMPLETED | 18 | 14 | 6 | 10 |
Baseline Characteristics
Arm/Group Title | Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | Total |
---|---|---|---|---|---|
Arm/Group Description | relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day | Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day | Treatment naive subjects treated with acalabrutinib 100 mg twice a day | Treatment naive subjects treated with acalabrutinib 200 mg once a day | Total of all reporting groups |
Overall Participants | 18 | 14 | 6 | 10 | 48 |
Age (Years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [Years] |
63.3
(9.3)
|
62.3
(7.7)
|
68.3
(10.9)
|
62.1
(8.7)
|
63.4
(8.9)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
6
33.3%
|
3
21.4%
|
2
33.3%
|
4
40%
|
15
31.3%
|
Male |
12
66.7%
|
11
78.6%
|
4
66.7%
|
6
60%
|
33
68.8%
|
Race/Ethnicity, Customized (Number) [Number] | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
2.1%
|
Not Hispanic or Latino |
18
100%
|
14
100%
|
6
100%
|
9
90%
|
47
97.9%
|
Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Number) [Number] | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
2
14.3%
|
0
0%
|
0
0%
|
2
4.2%
|
Black or African American |
2
11.1%
|
0
0%
|
2
33.3%
|
1
10%
|
5
10.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
16
88.9%
|
12
85.7%
|
4
66.7%
|
7
70%
|
39
81.3%
|
Not Reported |
0
0%
|
0
0%
|
0
0%
|
2
20%
|
2
4.2%
|
Region of Enrollment (Number) [Number] | |||||
United States |
18
100%
|
14
100%
|
6
100%
|
10
100%
|
48
100%
|
Outcome Measures
Title | Response Based on Overall Response Rate |
---|---|
Description | The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant. |
Time Frame | Cycle 1 (28 Days) to 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Total Relapse/Refractory Subjects | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | Total Treatment Naive Subjects |
---|---|---|---|---|---|---|
Arm/Group Description | relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day | Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day | All relapse/refractory subjects in both dose groups combined | Treatment naive subjects treated with acalabrutinib 100 mg twice a day | Treatment naive subjects treated with acalabrutinib 200 mg once a day | All treatment naive subjects in both dose groups combined |
Measure Participants | 18 | 13 | 31 | 6 | 10 | 16 |
Count of Participants [Participants] |
17
94.4%
|
11
78.6%
|
28
466.7%
|
6
60%
|
8
16.7%
|
14
NaN
|
Adverse Events
Time Frame | From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | ||||
Arm/Group Description | relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day | Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day | Treatment naive subjects treated with acalabrutinib 100 mg twice a day | Treatment naive subjects treated with acalabrutinib 200 mg once a day | ||||
All Cause Mortality |
||||||||
Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/18 (0%) | 1/14 (7.1%) | 0/6 (0%) | 0/10 (0%) | ||||
Serious Adverse Events |
||||||||
Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 11/18 (61.1%) | 8/14 (57.1%) | 3/6 (50%) | 5/10 (50%) | ||||
Blood and lymphatic system disorders | ||||||||
Febrile neutropenia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cardiac disorders | ||||||||
Cardiac failure | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Left ventricular dysfunction | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Ear and labyrinth disorders | ||||||||
Vertigo | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Abdominal distension | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Diverticular perforation | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Enterocolitis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Upper gastrointestinal haemorrhage | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
General disorders | ||||||||
Non-cardiac chest pain | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pyrexia | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hepatobiliary disorders | ||||||||
Cholecystitis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hepatic failure | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Infections and infestations | ||||||||
Diverticulitis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 2 |
Hepatitis b reactivation | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lower respiratory tract infection fungal | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pneumonia | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pneumonia influenzal | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Skin infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Upper respiratory tract infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Neck pain | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Lung adenocarcinoma | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Malignant melanoma | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Myelodysplastic syndrome | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Plasma cell myeloma | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Prostate cancer | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Prostate cancer metastatic | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Renal cell carcinoma | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Squamous cell carcinoma | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Nervous system disorders | ||||||||
Headache | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Syncope | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Pleuritic pain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Vascular disorders | ||||||||
Haematoma | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypotension | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
Acalabrutinib 100 mg BID Relapse/Refractory | Acalabrutinib 200 mg QD Relapse/Refractory | Acalabrutinib 100 mg BID Treatment Naive | Acalabrutinib 200 mg QD Treatment Naive | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 18/18 (100%) | 14/14 (100%) | 6/6 (100%) | 10/10 (100%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 3/6 (50%) | 4 | 1/10 (10%) | 1 |
Autoimmune haemolytic anaemia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Febrile neutropenia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hyperglobulinaemia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Increased tendency to bruise | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lymph node pain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Polycythaemia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Splenomegaly | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cardiac disorders | ||||||||
Angina pectoris | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Aortic valve disease | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Aortic valve incompetence | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Arrhythmia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Atrial flutter | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Atrioventricular block first degree | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Bradycardia | 0/18 (0%) | 0 | 1/14 (7.1%) | 3 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cardiac failure | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Cardiomegaly | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Coronary artery disease | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Palpitations | 2/18 (11.1%) | 3 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 2/10 (20%) | 3 |
Pericardial effusion | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Pericarditis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pulmonary valve disease | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Sinus bradycardia | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 2/10 (20%) | 2 |
Sinus tachycardia | 1/18 (5.6%) | 1 | 2/14 (14.3%) | 3 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Supraventricular tachycardia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Ventricular arrhythmia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Ventricular extrasystoles | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Ear and labyrinth disorders | ||||||||
Ear congestion | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Ear discomfort | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Ear pruritus | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
External ear inflammation | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypoacusis | 0/18 (0%) | 0 | 2/14 (14.3%) | 3 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Middle ear inflammation | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Tinnitus | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Vertigo | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Endocrine disorders | ||||||||
Adrenal mass | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypothyroidism | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Thyroid mass | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Eye disorders | ||||||||
Age-related macular degeneration | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Asthenopia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Blepharospasm | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Cataract | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Conjunctival haemorrhage | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 0/10 (0%) | 0 |
Conjunctival hyperaemia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Dry eye | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 1/10 (10%) | 1 |
Eye haemorrhage | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Eye pain | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Keratitis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Lacrimation increased | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lenticular opacities | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Ocular hypertension | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Photophobia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Retinal tear | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Uveitis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Vision blurred | 1/18 (5.6%) | 1 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Vitreous floaters | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 3/10 (30%) | 3 |
Vitreous haemorrhage | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Abdominal discomfort | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Abdominal distension | 1/18 (5.6%) | 1 | 2/14 (14.3%) | 2 | 2/6 (33.3%) | 3 | 1/10 (10%) | 1 |
Abdominal hernia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Abdominal pain | 2/18 (11.1%) | 3 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 2/10 (20%) | 2 |
Abdominal pain upper | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Anal fissure | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Anal incontinence | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Colitis | 0/18 (0%) | 0 | 1/14 (7.1%) | 3 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Constipation | 3/18 (16.7%) | 4 | 1/14 (7.1%) | 2 | 0/6 (0%) | 0 | 1/10 (10%) | 2 |
Dental caries | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Diarrhoea | 7/18 (38.9%) | 12 | 7/14 (50%) | 13 | 4/6 (66.7%) | 5 | 4/10 (40%) | 9 |
Dry mouth | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 0/10 (0%) | 0 |
Dyspepsia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 4/10 (40%) | 5 |
Dysphagia | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Flatulence | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Food poisoning | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Frequent bowel movements | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gastritis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Gastrointestinal disorder | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Gastrointestinal sounds abnormal | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gastrooesophageal reflux disease | 1/18 (5.6%) | 1 | 2/14 (14.3%) | 2 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Haemorrhoidal haemorrhage | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Haemorrhoids | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Intestinal perforation | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Large intestine polyp | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Mouth haemorrhage | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Nausea | 5/18 (27.8%) | 8 | 6/14 (42.9%) | 7 | 2/6 (33.3%) | 2 | 3/10 (30%) | 7 |
Oesophagitis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Oral dysaesthesia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Poor dental condition | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Rectal haemorrhage | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Retching | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Stomatitis | 3/18 (16.7%) | 3 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Tongue discolouration | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Toothache | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Umbilical hernia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Vomiting | 3/18 (16.7%) | 3 | 5/14 (35.7%) | 6 | 0/6 (0%) | 0 | 2/10 (20%) | 4 |
General disorders | ||||||||
Chest discomfort | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Chest pain | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Chills | 2/18 (11.1%) | 2 | 2/14 (14.3%) | 2 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Cyst | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Facial pain | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Fatigue | 4/18 (22.2%) | 5 | 5/14 (35.7%) | 6 | 4/6 (66.7%) | 6 | 3/10 (30%) | 4 |
Feeling abnormal | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hernia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Inflammation | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Influenza like illness | 7/18 (38.9%) | 14 | 9/14 (64.3%) | 15 | 3/6 (50%) | 6 | 8/10 (80%) | 15 |
Injection site bruising | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Injection site pain | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Injection site reaction | 3/18 (16.7%) | 3 | 1/14 (7.1%) | 3 | 0/6 (0%) | 0 | 3/10 (30%) | 4 |
Localised oedema | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Non-cardiac chest pain | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Oedema | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Oedema peripheral | 3/18 (16.7%) | 3 | 4/14 (28.6%) | 5 | 5/6 (83.3%) | 7 | 2/10 (20%) | 2 |
Pain | 0/18 (0%) | 0 | 1/14 (7.1%) | 2 | 2/6 (33.3%) | 3 | 2/10 (20%) | 2 |
Pyrexia | 4/18 (22.2%) | 5 | 3/14 (21.4%) | 3 | 0/6 (0%) | 0 | 4/10 (40%) | 9 |
Hepatobiliary disorders | ||||||||
Cholelithiasis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Dilatation intrahepatic duct acquired | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hepatic mass | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Immune system disorders | ||||||||
Allergy to arthropod sting | 0/18 (0%) | 0 | 2/14 (14.3%) | 3 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Drug hypersensitivity | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Hypogammaglobulinaemia | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 2/6 (33.3%) | 2 | 0/10 (0%) | 0 |
Seasonal allergy | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Infections and infestations | ||||||||
Abscess oral | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Bacterial vaginosis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Bronchitis | 3/18 (16.7%) | 4 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cellulitis | 2/18 (11.1%) | 3 | 2/14 (14.3%) | 3 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Chronic sinusitis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Clostridium difficile colitis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Conjunctivitis | 1/18 (5.6%) | 1 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Cystitis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Diverticulitis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Erythema migrans | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Eye infection | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Fungal skin infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gastroenteritis viral | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gingivitis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Herpes virus infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Herpes zoster | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Herpes zoster reactivation | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Laryngitis | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 2 |
Lip infection | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Localised infection | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lyme disease | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Mucosal infection | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Mycobacterium avium complex infection | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Nasopharyngitis | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Onychomycosis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Oral candidiasis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Oral herpes | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Otitis media | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pneumocystis jirovecii pneumonia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Pneumonia | 2/18 (11.1%) | 2 | 2/14 (14.3%) | 4 | 1/6 (16.7%) | 1 | 3/10 (30%) | 3 |
Prostate infection | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Sinusitis | 4/18 (22.2%) | 8 | 3/14 (21.4%) | 3 | 3/6 (50%) | 4 | 1/10 (10%) | 1 |
Skin infection | 3/18 (16.7%) | 3 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Tinea versicolour | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Tooth infection | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Upper respiratory tract infection | 9/18 (50%) | 13 | 6/14 (42.9%) | 12 | 3/6 (50%) | 4 | 5/10 (50%) | 10 |
Urinary tract infection | 3/18 (16.7%) | 7 | 3/14 (21.4%) | 3 | 2/6 (33.3%) | 2 | 1/10 (10%) | 1 |
Vaginal infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Varicella zoster virus infection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Viral infection | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Viral upper respiratory tract infection | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||
Animal bite | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Arthropod bite | 3/18 (16.7%) | 4 | 2/14 (14.3%) | 2 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Cartilage injury | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Contusion | 11/18 (61.1%) | 16 | 9/14 (64.3%) | 14 | 6/6 (100%) | 11 | 6/10 (60%) | 12 |
Epicondylitis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Fall | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Foot fracture | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hand fracture | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Infusion related reaction | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Ligament sprain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Limb injury | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Mouth injury | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 2/10 (20%) | 2 |
Muscle strain | 3/18 (16.7%) | 3 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Post procedural contusion | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Post procedural haemorrhage | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Road traffic accident | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin abrasion | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin laceration | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Spinal fracture | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Tooth fracture | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Investigations | ||||||||
Alanine aminotransferase increased | 2/18 (11.1%) | 3 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Aspartate aminotransferase increased | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 2/10 (20%) | 2 |
Beta 2 microglobulin increased | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 3 | 1/6 (16.7%) | 3 | 0/10 (0%) | 0 |
Bilirubin conjugated increased | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Blood alkaline phosphatase | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Blood alkaline phosphatase increased | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Blood bilirubin increased | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Blood creatine phosphokinase increased | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Blood creatinine increased | 3/18 (16.7%) | 5 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 4/10 (40%) | 7 |
Blood lactate dehydrogenase increased | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Blood urea decreased | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Blood urea increased | 2/18 (11.1%) | 2 | 2/14 (14.3%) | 2 | 1/6 (16.7%) | 1 | 3/10 (30%) | 3 |
C-reactive protein increased | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 2/10 (20%) | 2 |
Cd4 lymphocytes decreased | 6/18 (33.3%) | 7 | 4/14 (28.6%) | 8 | 3/6 (50%) | 4 | 0/10 (0%) | 0 |
Cardiac murmur | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Ejection fraction decreased | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Electrocardiogram qt prolonged | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Fibrin d dimer increased | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Haemoglobin increased | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Haptoglobin decreased | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
International normalised ratio increased | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Lymphocyte count decreased | 3/18 (16.7%) | 8 | 3/14 (21.4%) | 13 | 3/6 (50%) | 10 | 0/10 (0%) | 0 |
Lymphocyte count increased | 3/18 (16.7%) | 4 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Neutrophil count decreased | 5/18 (27.8%) | 6 | 6/14 (42.9%) | 11 | 1/6 (16.7%) | 1 | 1/10 (10%) | 5 |
Neutrophil count increased | 2/18 (11.1%) | 3 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 2/10 (20%) | 2 |
Platelet count decreased | 4/18 (22.2%) | 14 | 2/14 (14.3%) | 2 | 2/6 (33.3%) | 7 | 3/10 (30%) | 5 |
Platelet count increased | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Prostatic specific antigen increased | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Weight decreased | 3/18 (16.7%) | 4 | 4/14 (28.6%) | 9 | 1/6 (16.7%) | 2 | 2/10 (20%) | 2 |
Weight increased | 5/18 (27.8%) | 13 | 3/14 (21.4%) | 9 | 4/6 (66.7%) | 12 | 2/10 (20%) | 4 |
White blood cell count decreased | 1/18 (5.6%) | 3 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Hyperchloraemia | 2/18 (11.1%) | 3 | 3/14 (21.4%) | 3 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Hyperglycaemia | 7/18 (38.9%) | 10 | 4/14 (28.6%) | 8 | 3/6 (50%) | 5 | 3/10 (30%) | 3 |
Hyperkalaemia | 2/18 (11.1%) | 3 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hyperlipidaemia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypermagnesaemia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hypernatraemia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hyperphosphataemia | 1/18 (5.6%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hyperuricaemia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 4 | 0/10 (0%) | 0 |
Hypoalbuminaemia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hypocalcaemia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypochloraemia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Hypoglycaemia | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hypokalaemia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hypophosphataemia | 3/18 (16.7%) | 4 | 3/14 (21.4%) | 4 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Iron deficiency | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Obesity | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Type 2 diabetes mellitus | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 6/18 (33.3%) | 7 | 5/14 (35.7%) | 8 | 3/6 (50%) | 7 | 5/10 (50%) | 9 |
Arthritis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Back pain | 3/18 (16.7%) | 3 | 0/14 (0%) | 0 | 1/6 (16.7%) | 3 | 1/10 (10%) | 2 |
Bone pain | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Coccydynia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Flank pain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Gouty arthritis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Joint stiffness | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Joint swelling | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Limb mass | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Muscle spasms | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Musculoskeletal chest pain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 2 | 1/10 (10%) | 1 |
Musculoskeletal pain | 1/18 (5.6%) | 1 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Myalgia | 8/18 (44.4%) | 10 | 8/14 (57.1%) | 13 | 1/6 (16.7%) | 2 | 5/10 (50%) | 7 |
Neck pain | 1/18 (5.6%) | 1 | 3/14 (21.4%) | 3 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Pain in extremity | 3/18 (16.7%) | 3 | 2/14 (14.3%) | 2 | 5/6 (83.3%) | 6 | 2/10 (20%) | 2 |
Pain in jaw | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Rotator cuff syndrome | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Spondylolisthesis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Trigger finger | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Basal cell carcinoma | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Dysplastic naevus | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Melanocytic naevus | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Papilloma | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Skin papilloma | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Squamous cell carcinoma | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Nervous system disorders | ||||||||
Amnesia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Ataxia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Carotid arteriosclerosis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Carotid artery stenosis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cervical radiculopathy | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Dizziness | 4/18 (22.2%) | 7 | 5/14 (35.7%) | 5 | 1/6 (16.7%) | 1 | 3/10 (30%) | 4 |
Headache | 12/18 (66.7%) | 20 | 10/14 (71.4%) | 15 | 5/6 (83.3%) | 10 | 6/10 (60%) | 11 |
Hypoaesthesia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Memory impairment | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 1/10 (10%) | 1 |
Meralgia paraesthetica | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Neuralgia | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Paraesthesia | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 2/10 (20%) | 2 |
Peripheral sensory neuropathy | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Presyncope | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Restless legs syndrome | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Syncope | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 3/10 (30%) | 3 |
Tremor | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Psychiatric disorders | ||||||||
Anxiety | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Depression | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Insomnia | 5/18 (27.8%) | 5 | 4/14 (28.6%) | 5 | 0/6 (0%) | 0 | 2/10 (20%) | 3 |
Phonophobia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Suicidal ideation | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Renal and urinary disorders | ||||||||
Chromaturia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Chronic kidney disease | 3/18 (16.7%) | 3 | 0/14 (0%) | 0 | 1/6 (16.7%) | 5 | 1/10 (10%) | 1 |
Haematuria | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Nocturia | 2/18 (11.1%) | 2 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pollakiuria | 3/18 (16.7%) | 4 | 2/14 (14.3%) | 2 | 3/6 (50%) | 3 | 1/10 (10%) | 2 |
Renal cyst | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Renal cyst haemorrhage | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Renal mass | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Urinary incontinence | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Urinary tract obstruction | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Reproductive system and breast disorders | ||||||||
Benign prostatic hyperplasia | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Erectile dysfunction | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Hydrometra | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Pelvic fluid collection | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Prostatic obstruction | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Asthma | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Bronchostenosis | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Cough | 9/18 (50%) | 11 | 2/14 (14.3%) | 2 | 3/6 (50%) | 4 | 5/10 (50%) | 6 |
Dysphonia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Dyspnoea | 3/18 (16.7%) | 3 | 5/14 (35.7%) | 7 | 3/6 (50%) | 5 | 3/10 (30%) | 4 |
Epistaxis | 2/18 (11.1%) | 5 | 2/14 (14.3%) | 3 | 0/6 (0%) | 0 | 1/10 (10%) | 3 |
Laryngeal inflammation | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lung infiltration | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lung opacity | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Nasal congestion | 6/18 (33.3%) | 9 | 3/14 (21.4%) | 3 | 2/6 (33.3%) | 2 | 4/10 (40%) | 4 |
Nasal polyps | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Nasal septum deviation | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Oropharyngeal pain | 3/18 (16.7%) | 3 | 2/14 (14.3%) | 2 | 2/6 (33.3%) | 2 | 1/10 (10%) | 1 |
Pleural effusion | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Productive cough | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 3 | 0/10 (0%) | 0 |
Pulmonary mass | 4/18 (22.2%) | 4 | 2/14 (14.3%) | 2 | 3/6 (50%) | 4 | 0/10 (0%) | 0 |
Rhinitis allergic | 3/18 (16.7%) | 3 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Rhinorrhoea | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Sinus disorder | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Sinus pain | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Sleep apnoea syndrome | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Upper-airway cough syndrome | 5/18 (27.8%) | 5 | 1/14 (7.1%) | 1 | 2/6 (33.3%) | 2 | 0/10 (0%) | 0 |
Wheezing | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Skin and subcutaneous tissue disorders | ||||||||
Actinic keratosis | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Alopecia | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Blister | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Blood blister | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Dermal cyst | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Dermatitis bullous | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Dermatitis contact | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Dry skin | 4/18 (22.2%) | 4 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Ecchymosis | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Erythema | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Hyperhidrosis | 1/18 (5.6%) | 1 | 3/14 (21.4%) | 3 | 1/6 (16.7%) | 1 | 3/10 (30%) | 4 |
Hyperkeratosis | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Nail ridging | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Night sweats | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Onychoclasis | 3/18 (16.7%) | 3 | 1/14 (7.1%) | 1 | 1/6 (16.7%) | 1 | 1/10 (10%) | 1 |
Pain of skin | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Petechiae | 5/18 (27.8%) | 5 | 4/14 (28.6%) | 5 | 0/6 (0%) | 0 | 5/10 (50%) | 8 |
Photosensitivity reaction | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Pruritus | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 3/10 (30%) | 4 |
Psoriasis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Purpura | 2/18 (11.1%) | 2 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Rash erythematous | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Rash maculo-papular | 5/18 (27.8%) | 7 | 8/14 (57.1%) | 17 | 1/6 (16.7%) | 1 | 4/10 (40%) | 6 |
Rosacea | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Seborrhoea | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin atrophy | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Skin exfoliation | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin haemorrhage | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin hyperpigmentation | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 2 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin hypopigmentation | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin lesion | 2/18 (11.1%) | 2 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Skin mass | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Skin ulcer | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Telangiectasia | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 1/6 (16.7%) | 1 | 0/10 (0%) | 0 |
Urticaria | 1/18 (5.6%) | 1 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Vascular disorders | ||||||||
Aortic aneurysm | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Aortic dilatation | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Fibromuscular dysplasia | 1/18 (5.6%) | 1 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Flushing | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Haematoma | 3/18 (16.7%) | 3 | 2/14 (14.3%) | 2 | 1/6 (16.7%) | 2 | 0/10 (0%) | 0 |
Hot flush | 1/18 (5.6%) | 1 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 4/10 (40%) | 4 |
Hypertension | 10/18 (55.6%) | 32 | 7/14 (50%) | 13 | 3/6 (50%) | 8 | 2/10 (20%) | 5 |
Hypotension | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Lymphoedema | 0/18 (0%) | 0 | 2/14 (14.3%) | 2 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Subclavian artery occlusion | 0/18 (0%) | 0 | 0/14 (0%) | 0 | 0/6 (0%) | 0 | 1/10 (10%) | 1 |
Venous thrombosis | 0/18 (0%) | 0 | 1/14 (7.1%) | 1 | 0/6 (0%) | 0 | 0/10 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Acerta Clinical Trials |
---|---|
Organization | Acerta Pharma B.V. |
Phone | 1-888-292-9613 |
acertamc@dlss.com |
- 15-H-0016