Trial Outcomes & Findings for Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease (NCT NCT04958642)

NCT ID: NCT04958642

Last Updated: 2023-08-29

Results Overview

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as an AE with onset on or after the start of adrabetadex treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline up to 5 years
• Results posted on: 2023-08-29

Participant Flow

This is an open-label extension phase of study VTS301 (Parts A/B) (NCT02534844). Participants who completed Part B and participants who completed National Institutes of Health (NIH) phase 1 study (Protocol 13-CH-0001) were eligible to participate in this study.

Participant milestones

Measure	Treatment Naive Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
Overall Study STARTED	18	13	35
Overall Study Received at Least 1 Dose of Study Drug	18	13	35
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	18	13	35

Reasons for withdrawal

Measure	Treatment Naive Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
Overall Study Transferred to OLEX program	3	0	5
Overall Study Death	0	0	1
Overall Study Withdrawal by Subject	4	9	13
Overall Study Investigator's Decision	0	0	1
Overall Study Adverse Event	1	0	1
Overall Study Termination by Sponsor/Regulatory Authorities	8	4	13
Overall Study Lost to Follow-up	1	0	0
Overall Study Transferred to EAP following study termination	0	0	1
Overall Study Transferred to Expanded Access Program	1	0	0

Baseline Characteristics

Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease

Baseline characteristics by cohort

Measure	Treatment Naive n=18 Participants Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I n=13 Participants Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B n=35 Participants Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Total n=66 Participants Total of all reporting groups
Age, Continuous	13.2 years STANDARD_DEVIATION 5.07 • n=5 Participants	17.5 years STANDARD_DEVIATION 6.16 • n=7 Participants	14.1 years STANDARD_DEVIATION 5.60 • n=5 Participants	14.5 years STANDARD_DEVIATION 5.70 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants	55 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 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	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 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	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as an AE with onset on or after the start of adrabetadex treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Measure	Treatment Naive n=18 Participants Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I n=13 Participants Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B n=35 Participants Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Any TEAEs	18 Participants	13 Participants	34 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	9 Participants	7 Participants	20 Participants

Adverse Events

Treatment Naive

Serious events: 9 serious events

Other events: 18 other events

Deaths: 1 deaths

Previously Treated in Phase I

Serious events: 7 serious events

Other events: 13 other events

Deaths: 0 deaths

Previously Treated in Part A/B

Serious events: 20 serious events

Other events: 34 other events

Deaths: 1 deaths

Serious adverse events

Measure	Treatment Naive n=18 participants at risk Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I n=13 participants at risk Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B n=35 participants at risk Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
Cardiac disorders Tachycardia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Deafness	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Deafness neurosensory	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Dysphagia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	11.4% 4/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Gingival bleeding	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Superior mesenteric artery syndrome	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Catheter site inflammation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Pyrexia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Appendicitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Cellulitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Herpes simplex pharyngitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Implant site infection	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Infectious mononucleosis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Influenza	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Meningitis bacterial	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Meningitis staphylococcal	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Sepsis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Stoma site cellulitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Urinary tract infection	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Intentional medical device removal by patient	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Food intolerance	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Hyponatraemia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Back pain	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Myosclerosis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Chorea	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Diplegia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Encephalopathy	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Epilepsy	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Generalised tonic-clonic seizure	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Headache	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Lethargy	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Paraesthesia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Seizure	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Seizure cluster	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Somnolence	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Spinal subarachnoid haemorrhage	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Spinal subdural haematoma	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Product Issues Device dislocation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Mania	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Reproductive system and breast disorders Acute respiratory failure	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.

Other adverse events

Measure	Treatment Naive n=18 participants at risk Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Phase I n=13 participants at risk Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	Previously Treated in Part A/B n=35 participants at risk Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
Nervous system disorders Movement disorder	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Muscle spasticity	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Petit mal epilepsy	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Rosacea	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Skin lesion	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Skin striae	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Vascular disorders Flushing	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Repetitive speech	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Blood and lymphatic system disorders Leukopenia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Cardiac disorders Palpitations	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Cardiac disorders Tachycardia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Deafness	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Deafness neurosensory	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Ear pain	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders External ear inflammation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Hypoacusis	50.0% 9/18 • Number of events 20 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	25.7% 9/35 • Number of events 12 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Neurosensory hypoacusis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Otorrhoea	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Tinnitus	33.3% 6/18 • Number of events 72 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Eye disorders Conjunctivitis allergic	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Eye disorders Eye pruritus	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Eye disorders Eye swelling	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Eye disorders Periorbital oedema	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Eye disorders Vision blurred	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Abdominal pain	22.2% 4/18 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Anal incontinence	11.1% 2/18 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Constipation	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	25.7% 9/35 • Number of events 15 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Dental caries	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Diarrhoea	50.0% 9/18 • Number of events 19 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	46.2% 6/13 • Number of events 14 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	40.0% 14/35 • Number of events 28 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Dry mouth	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Dysphagia	22.2% 4/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	46.2% 6/13 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	17.1% 6/35 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Faeces soft	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Gastritis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Gastrointestinal disorder	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Malpositioned teeth	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Nausea	22.2% 4/18 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	17.1% 6/35 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Oral disorder	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Retained deciduous tooth	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Retching	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Salivary hypersecretion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Toothache	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Gastrointestinal disorders Vomiting	66.7% 12/18 • Number of events 26 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	69.2% 9/13 • Number of events 24 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	45.7% 16/35 • Number of events 25 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Adverse drug reaction	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Application site rash	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Asthenia	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Catheter site haematoma	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Catheter site swelling	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Cyst	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Discomfort	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Fatigue	44.4% 8/18 • Number of events 101 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	38.5% 5/13 • Number of events 11 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	37.1% 13/35 • Number of events 146 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Gait disturbance	11.1% 2/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	46.2% 6/13 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	28.6% 10/35 • Number of events 55 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Infusion site extravasation	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Malaise	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Oedema peripheral	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Pain	5.6% 1/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Peripheral swelling	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Pyrexia	33.3% 6/18 • Number of events 13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	69.2% 9/13 • Number of events 48 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	48.6% 17/35 • Number of events 36 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
General disorders Swelling	5.6% 1/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Hepatobiliary disorders Hepatosplenomegaly	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Immune system disorders Anaphylactic reaction	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Immune system disorders Drug hypersensitivity	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Immune system disorders Hypersensitivity	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Immune system disorders Seasonal allergy	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 8 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Abscess limb	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Bronchitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations COVID-19	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Cellulitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Conjunctivitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Cystitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Ear infection	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Folliculitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Fungal skin infection	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Gastroenteritis	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Gastroenteritis viral	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Genital infection fungal	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Gingivitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Hordeolum	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Influenza	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Laryngitis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Nasopharyngitis	16.7% 3/18 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	20.0% 7/35 • Number of events 13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Oral herpes	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Otitis externa	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Otitis media	5.6% 1/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Otitis media acute	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Paronychia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pharyngitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pharyngitis streptococcal	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pilonidal cyst	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Pneumonia mycoplasmal	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Respiratory tract infection	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Rhinitis	16.7% 3/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	20.0% 7/35 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Sinusitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Skin infection	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Tonsillitis	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Tooth infection	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Upper respiratory tract infection	61.1% 11/18 • Number of events 34 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	53.8% 7/13 • Number of events 27 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	28.6% 10/35 • Number of events 24 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Urinary tract infection	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Seizure	5.6% 1/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 34 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	22.9% 8/35 • Number of events 14 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Varicella	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Viral infection	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Administration related reaction	11.1% 2/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Ankle fracture	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Arthropod bite	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Bone contusion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Contusion	11.1% 2/18 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	53.8% 7/13 • Number of events 17 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 29 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Eye contusion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Face injury	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Fall	27.8% 5/18 • Number of events 37 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	53.8% 7/13 • Number of events 42 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	45.7% 16/35 • Number of events 117 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Foot fracture	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Head injury	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Ligament sprain	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Limb injury	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Lip injury	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Nail injury	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Oral contusion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Procedural complication	5.6% 1/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 33 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Procedural pain	16.7% 3/18 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 15 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Sedation complication	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Skin abrasion	11.1% 2/18 • Number of events 9 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	46.2% 6/13 • Number of events 15 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	31.4% 11/35 • Number of events 33 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Skin laceration	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	11.4% 4/35 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Wound complication	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Activated partial thromboplastin time prolonged	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Body temperature increased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Electroencephalogram abnormal	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Mean cell volume decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Oxygen saturation decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations PO2 decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Platelet count decreased	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Prothrombin time prolonged	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Respiratory rate increased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations SARS-CoV-2 test positive	16.7% 3/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Vitamin D decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Weight decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Investigations Weight increased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Metabolism and nutrition disorders Iron deficiency	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Infections and infestations Polydipsia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Back pain	44.4% 8/18 • Number of events 36 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	69.2% 9/13 • Number of events 74 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	51.4% 18/35 • Number of events 142 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 14 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Haemarthrosis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Joint swelling	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 16 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.1% 2/18 • Number of events 18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 10 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Myositis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 6/18 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	20.0% 7/35 • Number of events 12 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Musculoskeletal and connective tissue disorders Scoliosis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Amnesia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Ataxia	50.0% 9/18 • Number of events 21 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	22.9% 8/35 • Number of events 78 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Atonic seizures	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Balance disorder	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	22.9% 8/35 • Number of events 15 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Cataplexy	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	14.3% 5/35 • Number of events 7 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Coordination abnormal	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Diplegia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Dizziness	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Dysarthria	16.7% 3/18 • Number of events 18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 64 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Dyskinesia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Dystonia	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Epilepsy	11.1% 2/18 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Headache	50.0% 9/18 • Number of events 29 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	69.2% 9/13 • Number of events 34 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	34.3% 12/35 • Number of events 79 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Hypoaesthesia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Hypotonia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Intracranial pressure increased	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Lethargy	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	11.4% 4/35 • Number of events 11 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Memory impairment	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Migraine	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Motor dysfunction	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Seizure cluster	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Somnolence	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Tremor	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Nervous system disorders Visual field defect	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Product Issues Device dislocation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Product Issues Device malfunction	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Aggression	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Agitation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Anxiety	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Communication disorder	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Daydreaming	5.6% 1/18 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Depressed mood	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Dyssomnia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Inappropriate affect	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Initial insomnia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Insomnia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Irritability	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Restlessness	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Sleep disorder	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Psychiatric disorders Suicidal ideation	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Dysuria	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Haematuria	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Incontinence	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Micturition urgency	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Nephrolithiasis	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Pollakiuria	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Proteinuria	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Urinary incontinence	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 9 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Urinary retention	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Urine abnormality	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Perineal rash	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Allergic respiratory symptom	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Renal and urinary disorders Apnoea	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Cough	27.8% 5/18 • Number of events 13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	46.2% 6/13 • Number of events 15 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	42.9% 15/35 • Number of events 29 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 2/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	25.7% 9/35 • Number of events 45 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 2/18 • Number of events 6 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	23.1% 3/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	17.1% 6/35 • Number of events 12 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 3/18 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Respiratory distress	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	30.8% 4/13 • Number of events 5 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Sinus congestion	11.1% 2/18 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Sneezing	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	11.1% 2/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	15.4% 2/13 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Dermatitis contact	5.6% 1/18 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Ingrowing nail	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	2.9% 1/35 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Papule	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Skin and subcutaneous tissue disorders Pruritus	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	7.7% 1/13 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/35 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Vascular disorders Haematoma	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 3 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Vascular disorders Hypotension	5.6% 1/18 • Number of events 1 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	8.6% 3/35 • Number of events 4 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Vascular disorders Orthostatic hypotension	0.00% 0/18 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	0.00% 0/13 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.	5.7% 2/35 • Number of events 2 • Baseline up to 5 years The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.

Additional Information

Executive Vice President, Regulatory Affairs

Mandos, LLC

Phone: 619-905-0489

Email: jspinella@mandoshealth.com

Results disclosure agreements

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