Trial Outcomes & Findings for A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease (NCT NCT02641392)

Last Updated: 2019-01-29

Results Overview

A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

310 participants

Primary outcome timeframe

From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose

Results posted on

2019-01-29

Participant Flow

310 adult participants who had previously participated in the main study GED-0301-CD-002 were enrolled at 167 study sites in 29 countries.

Includes participants with Crohn's disease who had previously participated in the main study GED-0301-CD-002 through Week 12 at minimum and completed participation through the last treatment visit at Week 52, or met the "early escape criteria" and were discontinued beginning at Week 12 through Week 52.

Participant milestones

Participant milestones
Measure	GED-0301 40 mg 4 Weeks Alt Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208	GED-0301 40 mg Participants received continuous GED-0301 40 mg daily, up to week 208.	GED-0301 160 mg 4 Weeks Alt Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks
Overall Study STARTED	4	13	293
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	4	13	293

Reasons for withdrawal

Reasons for withdrawal
Measure	GED-0301 40 mg 4 Weeks Alt Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208	GED-0301 40 mg Participants received continuous GED-0301 40 mg daily, up to week 208.	GED-0301 160 mg 4 Weeks Alt Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks
Overall Study Lost to Follow-up	0	0	2
Overall Study Withdrawal by Subject	0	0	17
Overall Study Adverse Event	0	1	25
Overall Study Study Terminated by Sponsor	4	12	144
Overall Study Lack of Efficacy	0	0	101
Overall Study Miscellaneous	0	0	3
Overall Study Death	0	0	1

Baseline Characteristics

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GED-0301 40 mg 4 Weeks Alt n=4 Participants Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208	GED-0301 40 mg n=13 Participants Participants received continuous GED-0301 40 mg daily, up to week 208.	GED-0301 160 mg 4 Weeks Alt n=293 Participants Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks	Total n=310 Participants Total of all reporting groups
Age, Continuous	35.3 Years STANDARD_DEVIATION 12.34 • n=5 Participants	41.8 Years STANDARD_DEVIATION 14.21 • n=7 Participants	38.1 Years STANDARD_DEVIATION 12.30 • n=5 Participants	38.2 Years STANDARD_DEVIATION 12.37 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	136 Participants n=5 Participants	145 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	157 Participants n=5 Participants	165 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	9 Participants n=7 Participants	264 Participants n=5 Participants	277 Participants n=4 Participants
Race/Ethnicity, Customized Not Collected or Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Duration of Crohn's Disease	7.25 Years STANDARD_DEVIATION 6.529 • n=5 Participants	9.25 Years STANDARD_DEVIATION 6.307 • n=7 Participants	10.56 Years STANDARD_DEVIATION 8.503 • n=5 Participants	10.46 Years STANDARD_DEVIATION 8.396 • n=4 Participants
Baseline Crohn's Disease Activity (CDAI) Score	316.9 units on a scale STANDARD_DEVIATION 96.90 • n=5 Participants	309.2 units on a scale STANDARD_DEVIATION 43.10 • n=7 Participants	307.5 units on a scale STANDARD_DEVIATION 62.74 • n=5 Participants	307.7 units on a scale STANDARD_DEVIATION 62.33 • n=4 Participants

PRIMARY outcome

Timeframe: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose

Population: Safety population includes participants who were received at least one dose of GED-0301. Participants were included in the group corresponding to the treatment regimen they actually received.

Outcome measures

Outcome measures
Measure	GED 40 mg 4 Weeks Alt n=4 Participants Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208	GED-0301 40 mg n=13 Participants Participants received continuous GED-0301 40 mg daily, up to week 208.	GED-0301 160 mg 4 Weeks Alt n=293 Participants Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any TEAE	1 Participants	6 Participants	189 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any Drug-Related TEAE	0 Participants	1 Participants	43 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any Severe TEAE	0 Participants	0 Participants	38 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any Serious TEAE (SAE)	1 Participants	0 Participants	41 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any Serious Drug-Related TEAE	0 Participants	0 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any TEAE Leading to IP Interruption	0 Participants	0 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any TEAE Leading to IP Withdrawal	0 Participants	1 Participants	27 Participants
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 Any TEAE Leading to Death	0 Participants	0 Participants	1 Participants

Adverse Events

GED-0301 40 mg 4 Weeks Alt

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

GED-0301 40 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

GED-0301 160 mg 4 Weeks Alt

Serious events: 41 serious events

Other events: 92 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee .Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	GED-0301 40 mg 4 Weeks Alt n=4 participants at risk Participants received alternating placebo daily for 4 weeks and GED-0301 40 mg daily for 4 weeks, up to week 208	GED-0301 40 mg n=13 participants at risk Participants received continuous GED-0301 40 mg daily, up to week 208.	GED-0301 160 mg 4 Weeks Alt n=293 participants at risk Participants received one of three dose regimens up to week 208: 1\) alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks or (2) alternating GED-0301 160 mg daily for 4 weeks and placebo daily for 4 weeks or (3) GED-0301 160 mg daily for 12 weeks, followed by alternating placebo daily for 4 weeks and GED-0301 160 mg daily for 4 weeks
Cardiac disorders CARDIAC VALVE DISEASE	25.0% 1/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	9.9% 29/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders ANAL FISTULA	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders APHTHOUS ULCER	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	10.2% 30/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders DIARRHOEA	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Gastrointestinal disorders ILEAL STENOSIS	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Hepatobiliary disorders GALLBLADDER DISORDER	25.0% 1/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Infections and infestations CYSTITIS	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	25.0% 1/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	6.8% 20/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	7.7% 1/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Investigations ELECTROCARDIOGRAM T WAVE INVERSION	25.0% 1/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Metabolism and nutrition disorders HYPERLIPIDAEMIA	25.0% 1/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	15.4% 2/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	9.2% 27/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Nervous system disorders HEADACHE	0.00% 0/4 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	0.00% 0/13 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose	5.5% 16/293 • From the first day of GED-0301 up tol 28 days after the last dose of GED-0301. Maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose