Trial Outcomes & Findings for A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies (NCT NCT03205046)

NCT ID: NCT03205046

Last Updated: 2021-01-06

Results Overview

Safety assessments comprised type, frequency, severity, and relationship to either or both study drug of any AEs or abnormalities of laboratory tests; serious adverse events (SAEs); dose-limiting toxicities (DLTs); or AEs that led to dose modification, dose delay, or discontinuation of study drug(s).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: From first dose of study drug until 30 days post last dose
• Results posted on: 2021-01-06

Participant Flow

Participant milestones

Measure	Acalabrutinib 100 mg BID Plus Vistusertib BID Continuous Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID Plus Vistusertib BID Intermittent Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
Overall Study STARTED	13	12
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Measure	Acalabrutinib 100 mg BID Plus Vistusertib BID Continuous Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID Plus Vistusertib BID Intermittent Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
Overall Study Death	10	6
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	0	1
Overall Study Study terminated by sponsor	2	1

Baseline Characteristics

A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Baseline characteristics by cohort

Measure	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous n=13 Participants Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent n=12 Participants Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle	Total n=25 Participants Total of all reporting groups
Age, Continuous	63.6 Years STANDARD_DEVIATION 15.9 • n=5 Participants	67.3 Years STANDARD_DEVIATION 12.0 • n=7 Participants	65.4 Years STANDARD_DEVIATION 13.99 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until 30 days post last dose

Safety assessments comprised type, frequency, severity, and relationship to either or both study drug of any AEs or abnormalities of laboratory tests; serious adverse events (SAEs); dose-limiting toxicities (DLTs); or AEs that led to dose modification, dose delay, or discontinuation of study drug(s).

Outcome measures

Measure	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous n=13 Participants Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent n=12 Participants Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
Number of Participants With Treatment-Emergent Adverse Events (AEs)	13 Participants	12 Participants

Adverse Events

Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous

Serious events: 2 serious events

Other events: 13 other events

Deaths: 10 deaths

Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent

Serious events: 6 serious events

Other events: 12 other events

Deaths: 6 deaths

Serious adverse events

Measure	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous n=13 participants at risk Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent n=12 participants at risk Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Asthenia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Pyrexia	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Cellulitis	7.7% 1/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Lower respiratory tract infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Pneumonia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Computerised tomogram thorax abnormal	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Syncope	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Trigeminal neuralgia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.

Other adverse events

Measure	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Continuous n=13 participants at risk Acalabrutinib daily + Vistusertib daily over the 28-day cycle	Acalabrutinib 100 mg BID* Plus Vistusertib BID* Intermittent n=12 participants at risk Acalabrutinib daily + Vistusertib 2 days on/ 5 days off over the 28-day cycle
Blood and lymphatic system disorders Anaemia	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	41.7% 5/12 • Number of events 7 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Leukopenia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 7 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	25.0% 3/12 • Number of events 13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Cardiac disorders Tachycardia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Eye disorders Periorbital oedema	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Constipation	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	50.0% 6/12 • Number of events 7 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Diarrhoea	46.2% 6/13 • Number of events 8 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 5 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Dry mouth	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	33.3% 4/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Dysphagia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	66.7% 8/12 • Number of events 10 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Stomatitis	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	41.7% 5/12 • Number of events 6 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Asthenia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Chest pain	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Chills	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Fatigue	30.8% 4/13 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	66.7% 8/12 • Number of events 10 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Influenza like illness	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Injection site bruising	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Mucosal inflammation	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Non-cardiac chest pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Oedema	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Oedema peripheral	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Peripheral swelling	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
General disorders Pyrexia	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Immune system disorders Seasonal allergy	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Candida infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Cellulitis	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Enterovirus infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Herpes zoster	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Lower respiratory tract infection	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Nasopharyngitis	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Oral candidiasis	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Respiratory tract infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Rhinovirus infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Sinusitis bacterial	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Tooth infection	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Injury, poisoning and procedural complications Fall	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Bacterial test positive	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Blood alkaline phosphatase increased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Blood creatinine increased	30.8% 4/13 • Number of events 5 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	58.3% 7/12 • Number of events 11 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Blood urea increased	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Ejection fraction decreased	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Electrocardiogram qt prolonged	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Electrocardiogram t wave abnormal	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Haemoglobin decreased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Lymphocyte count decreased	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Platelet count decreased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Investigations Weight decreased	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	25.0% 3/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	50.0% 6/12 • Number of events 6 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hyperglycaemia	23.1% 3/13 • Number of events 5 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	41.7% 5/12 • Number of events 7 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 5 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypokalaemia	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	25.0% 3/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 5 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Musculoskeletal and connective tissue disorders Myalgia	15.4% 2/13 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	25.0% 3/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Disturbance in attention	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Dizziness	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Dysgeusia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	33.3% 4/12 • Number of events 6 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Neuralgia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Neuropathy peripheral	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Paraesthesia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Presyncope	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Nervous system disorders Trigeminal neuralgia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Psychiatric disorders Agitation	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Psychiatric disorders Anxiety	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Psychiatric disorders Confusional state	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	25.0% 3/12 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Psychiatric disorders Depressed mood	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Psychiatric disorders Insomnia	23.1% 3/13 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Renal and urinary disorders Chronic kidney disease	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Renal and urinary disorders Pollakiuria	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Reproductive system and breast disorders Breast mass	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	33.3% 4/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Erythema	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Pruritus	23.1% 3/13 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 2 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Rash	23.1% 3/13 • Number of events 3 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	16.7% 2/12 • Number of events 4 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Vascular disorders Hypotension	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	41.7% 5/12 • Number of events 6 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Vascular disorders Orthostatic hypotension	7.7% 1/13 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	0.00% 0/12 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.
Vascular disorders Peripheral ischaemia	0.00% 0/13 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.	8.3% 1/12 • Number of events 1 • Serious Adverse Events and Other Adverse Events were assessed from first dose of study drug until 30 days post last dose; All-Cause Mortality was assessed from first dose of study drug until death, loss to follow up, sponsor decision to stop trial, or withdrawal of consent, whichever occurred first, an average of approximately 6 months.

Additional Information

Acerta Clinical Trials

Acerta Pharma B.V.

Phone: 1-888-292-9613

Email: acertamc@dlss.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place