Trial Outcomes & Findings for ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment (NCT NCT02735863)

Last Updated: 2024-09-19

Results Overview

Patients who had received at least one dose of the study drug, and who had at least one baseline value. An AE was classified as a TEAE if it started, or increased in severity, on or after the first date and time of medication dosing (from Day 1 up to Day 28). Any AE which occurred after Day 28 was classified as post-treatment-emergent. Events were graded according to the "Division of AIDS table for grading the severity of adult and pediatric adverse events" (Version 2.0 November 2014).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 4 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	ABX464 50mg Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo
Overall Study STARTED	6	16	8
Overall Study COMPLETED	5	14	7
Overall Study NOT COMPLETED	1	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABX464 50mg n=6 Participants Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg n=16 Participants Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo n=8 Participants Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 3.5 • n=5 Participants	38.4 years STANDARD_DEVIATION 10.4 • n=7 Participants	48.3 years STANDARD_DEVIATION 8.5 • n=5 Participants	42.4 years STANDARD_DEVIATION 9.8 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment France	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: Patients who had received at least one dose of the study drug, and who had at least one baseline value.

Outcome measures

Outcome measures
Measure	ABX464 50mg n=6 Participants Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg n=16 Participants Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo n=8 Participants Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo
Number of Participants With Adverse Events Any post-TEAE	4 Participants	6 Participants	4 Participants
Number of Participants With Adverse Events Any serious AE	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Any severe AE	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events AE leading to death	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any AE	5 Participants	15 Participants	7 Participants
Number of Participants With Adverse Events Any TEAE	4 Participants	15 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Population: Patients who had received at least one dose of the study drug, and who had at least one baseline value.

Time To Viral Rebound is defined as the time between treatment stop (i.e. day 29) and viral rebound detection

Outcome measures

Outcome measures
Measure	ABX464 50mg n=6 Participants Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg n=16 Participants Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo n=8 Participants Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo
Time to Viral Rebound	17.2 days Standard Deviation 3.4	14.4 days Standard Deviation 7.4	14.4 days Standard Deviation 7.3

Adverse Events

ABX464 50mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ABX464 150mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

ABX464 Matching Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABX464 50mg n=6 participants at risk Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg n=16 participants at risk Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo n=8 participants at risk Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo
Nervous system disorders vagal faintness	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Fatigue	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.

Other adverse events

Additional Information

Sharon Skare

ABIVAX

Phone: +33153830961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	ABX464 50mg n=6 participants at risk Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 150mg n=16 participants at risk Fixed dose of ABX464 150mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)	ABX464 Matching Placebo n=8 participants at risk Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Placebo: ABX464 matching placebo
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	18.8% 3/16 • Number of events 4 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	25.0% 4/16 • Number of events 5 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	18.8% 3/16 • Number of events 5 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 2/16 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Fatigue	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	18.8% 3/16 • Number of events 5 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Influenza Like Illness	16.7% 1/6 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	25.0% 2/8 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Sinusitis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Investigations C-reactive Protein Increased	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Injury, poisoning and procedural complications Scar	16.7% 1/6 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 2/16 • Number of events 3 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	31.2% 5/16 • Number of events 6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	31.2% 5/16 • Number of events 7 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Blood and lymphatic system disorders Lymphadenopathy	16.7% 1/6 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Gastric disorder	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Salivary gland disorder	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Tooth infection	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Gastrointestinal disorders Toothache	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Inflammation	16.7% 1/6 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Malaise	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Oedema peripheral	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 2 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Peripheral swelling	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Pyrexia	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Bronchitis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Eye infection	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Pharyngitis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Rhinitis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Infections and infestations Syphilis	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
General disorders Upper respiratory tract infection	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Psychiatric disorders Insomnia	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Renal and urinary disorders Dysuria	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	6.2% 1/16 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/8 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	0.00% 0/16 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.	12.5% 1/8 • Number of events 1 • Up to 4 months Patients who had received at least one dose of the study drug, and who had at least one baseline value.