Trial Outcomes & Findings for A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency (NCT NCT05171855)

Last Updated: 2026-01-09

Results Overview

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE was any untoward medical occurrence at any dose that met any of the following criteria: resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the trial drug or was considered a significant medical event by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

220 participants

Primary outcome timeframe

Up to 52 Weeks

Results posted on

2026-01-09

Participant Flow

The study TCH-306 EXT enrolled participants who had completed treatment in TCH-306 (NCT04615273) study. In Japan only, participants switched from commercially available somatropin therapy (results reported separately).

Participant milestones

Participant milestones
Measure	Lonapegsomatropin/Lonapegsomatropin Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Overall Study STARTED	73	73	74
Overall Study COMPLETED	67	69	66
Overall Study NOT COMPLETED	6	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Lonapegsomatropin/Lonapegsomatropin Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Overall Study Death	1	0	0
Overall Study Withdrawal by Subject	2	0	5
Overall Study Physician Decision	1	0	0
Overall Study Adverse Event	2	4	2
Overall Study Other	0	0	1

Baseline Characteristics

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lonapegsomatropin/Lonapegsomatropin n=73 Participants Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=73 Participants Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=74 Participants Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Total n=220 Participants Total of all reporting groups
Age, Customized < 30 years	10 Participants n=8 Participants	13 Participants n=7 Participants	14 Participants n=15 Participants	37 Participants n=42 Participants
Age, Customized >= 30 to <= 60 years	53 Participants n=8 Participants	51 Participants n=7 Participants	52 Participants n=15 Participants	156 Participants n=42 Participants
Age, Customized > 60 years	10 Participants n=8 Participants	9 Participants n=7 Participants	8 Participants n=15 Participants	27 Participants n=42 Participants
Sex: Female, Male Female	37 Participants n=8 Participants	32 Participants n=7 Participants	31 Participants n=15 Participants	100 Participants n=42 Participants
Sex: Female, Male Male	36 Participants n=8 Participants	41 Participants n=7 Participants	43 Participants n=15 Participants	120 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=8 Participants	3 Participants n=7 Participants	5 Participants n=15 Participants	11 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=8 Participants	69 Participants n=7 Participants	67 Participants n=15 Participants	204 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=8 Participants	1 Participants n=7 Participants	2 Participants n=15 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=8 Participants	1 Participants n=7 Participants	0 Participants n=15 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian	9 Participants n=8 Participants	7 Participants n=7 Participants	8 Participants n=15 Participants	24 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=8 Participants	0 Participants n=7 Participants	1 Participants n=15 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	59 Participants n=8 Participants	62 Participants n=7 Participants	64 Participants n=15 Participants	185 Participants n=42 Participants
Race/Ethnicity, Customized Other	5 Participants n=8 Participants	3 Participants n=7 Participants	1 Participants n=15 Participants	9 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 52 Weeks

Population: Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.

Outcome measures

Outcome measures
Measure	Lonapegsomatropin/Lonapegsomatropin n=73 Participants Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=73 Participants Participants who had completed treatment with placebo in TCH-306 study were enrolled in the study and extension study lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=74 Participants Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation TEAEs	48 Participants	52 Participants	45 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation Serious TEAEs	7 Participants	4 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation TEAE Leading to Study Discontinuation	2 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline main trial to week 52 (extension period)

Population: Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.

Trunk percent fat was assessed by dual-energy X-ray absorptiometry.

Outcome measures

Outcome measures
Measure	Lonapegsomatropin/Lonapegsomatropin n=67 Participants Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=69 Participants Participants who had completed treatment with placebo in TCH-306 study were enrolled in the study and extension study lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=66 Participants Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Change From Baseline in Trunk Percent Fat at Week 52	-1.21 percent fat Interval -2.41 to -0.01	-1.60 percent fat Interval -2.35 to -0.86	-1.11 percent fat Interval -2.05 to -0.17

SECONDARY outcome

Timeframe: Baseline main trial to week 52 (extension period)

Population: Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.

Trunk fat mass was assessed by dual-energy X-ray absorptiometry.

Outcome measures

Outcome measures
Measure	Lonapegsomatropin/Lonapegsomatropin n=67 Participants Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=69 Participants Participants who had completed treatment with placebo in TCH-306 study were enrolled in the study and extension study lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=66 Participants Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Change From Baseline in Trunk Fat Mass at Week 52	0.15 kilograms Interval -0.47 to 0.77	-0.16 kilograms Interval -0.63 to 0.31	-0.00 kilograms Interval -0.53 to 0.53

SECONDARY outcome

Timeframe: Baseline main trial to week 52 (extension period)

Population: Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.

Total body lean mass was assessed by dual-energy X-ray absorptiometry.

Outcome measures

Outcome measures
Measure	Lonapegsomatropin/Lonapegsomatropin n=67 Participants Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=69 Participants Participants who had completed treatment with placebo in TCH-306 study were enrolled in the study and extension study lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=66 Participants Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Change From Baseline in Total Body Lean Mass at Week 52	2.26 kilograms Interval 1.47 to 3.05	1.97 kilograms Interval 1.15 to 2.8	2.07 kilograms Interval 1.21 to 2.94

Adverse Events

Lonapegsomatropin/Lonapegsomatropin

Serious events: 7 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo/Lonapegsomatropin

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Somatropin/Lonapegsomatropin

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Lonapegsomatropin/Lonapegsomatropin n=73 participants at risk Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=73 participants at risk Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=74 participants at risk Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Investigations Haematocrit increased	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	6.8% 5/73 • Number of events 5 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
General disorders Oedema peripheral	1.4% 1/73 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.5% 4/73 • Number of events 8 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Gastrointestinal disorders Gastroenteritis	2.7% 2/73 • Number of events 2 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	6.8% 5/73 • Number of events 5 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
General disorders Pyrexia	1.4% 1/73 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.4% 4/74 • Number of events 6 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations Influenza	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	8.2% 6/73 • Number of events 10 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	9.6% 7/73 • Number of events 11 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	9.6% 7/73 • Number of events 11 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	10.8% 8/74 • Number of events 8 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations Nasopharyngitis	16.4% 12/73 • Number of events 17 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	8.2% 6/73 • Number of events 10 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	2.7% 2/74 • Number of events 2 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
General disorders Headache	6.8% 5/73 • Number of events 6 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	6.8% 5/73 • Number of events 5 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.4% 4/74 • Number of events 6 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations COVID-19	5.5% 4/73 • Number of events 4 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.5% 4/73 • Number of events 4 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	2.7% 2/74 • Number of events 2 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Nervous system disorders Dizziness	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	8.2% 6/73 • Number of events 7 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.4% 4/74 • Number of events 11 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Musculoskeletal and connective tissue disorders Back pain	2.7% 2/73 • Number of events 3 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	6.8% 5/73 • Number of events 5 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	2.7% 2/74 • Number of events 2 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Musculoskeletal and connective tissue disorders Arthralgia	2.7% 2/73 • Number of events 4 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	6.8% 5/73 • Number of events 11 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
General disorders Fatigue	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	5.5% 4/73 • Number of events 5 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • Number of events 1 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.

Additional Information

Aimee D. Shu, MD

Ascendis Pharma

Phone: +1 650-461-4835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lonapegsomatropin/Lonapegsomatropin n=73 participants at risk Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Placebo/Lonapegsomatropin n=73 participants at risk Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.	Somatropin/Lonapegsomatropin n=74 participants at risk Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Infections and infestations Sepsis	2.7% 2/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations Clostridium difficile colitis	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations Norovirus infection	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Infections and infestations Infected seroma	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Endocrine disorders Adrenocortical insufficiency acute	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Endocrine disorders Hyperparathyroidism	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Nervous system disorders Cerebrovascular accident	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Nervous system disorders Seizure	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Nervous system disorders Cerebral cyst	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Gastrointestinal disorders Enterocolitis	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Gastrointestinal disorders Gastritis	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Gastrointestinal disorders Abdominal hernia	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Hepatobiliary disorders Cholelithiasis	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Blood and lymphatic system disorders Sarcoidosis of lymph node	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	0.00% 0/73 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.	1.4% 1/74 • From first dose of the study drug up to Week 52 Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.