Trial Outcomes & Findings for Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine (NCT NCT05264129)

Last Updated: 2024-10-08

Results Overview

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. A treatment-emergent adverse event (TEAE) is an AE that occurs or worsens after receiving investigational study drug.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

263 participants

Primary outcome timeframe

From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

Results posted on

2024-10-08

Participant Flow

A total of 263 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant withdrew consent before receiving study drug and therefore was not included in the demographics or any analyses.

Participant milestones

Participant milestones
Measure	Atogepant 60 mg (Period 1) Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Period 1 Atogepant (Day1 to Wk12) STARTED	262	0
Period 1 Atogepant (Day1 to Wk12) COMPLETED	221	0
Period 1 Atogepant (Day1 to Wk12) NOT COMPLETED	41	0
Period 2 Atogepant+Ubrogepant (Wk12-24) STARTED	0	218
Period 2 Atogepant+Ubrogepant (Wk12-24) COMPLETED	0	203
Period 2 Atogepant+Ubrogepant (Wk12-24) NOT COMPLETED	0	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1 then atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Age, Customized Age Group · < 20 years	0 Participants n=99 Participants
Age, Customized Age Group · 20 to 29 years	43 Participants n=99 Participants
Age, Customized Age Group · 30 to 39 years	60 Participants n=99 Participants
Age, Customized Age Group · 40 to 49 years	71 Participants n=99 Participants
Age, Customized Age Group · 50 to 59 years	53 Participants n=99 Participants
Age, Customized Age Group · 60 to 69 years	33 Participants n=99 Participants
Age, Customized Age Group · ≥ 70 years	2 Participants n=99 Participants
Sex: Female, Male Female	214 Participants n=99 Participants
Sex: Female, Male Male	48 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	235 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	8 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	44 Participants n=99 Participants
Race (NIH/OMB) White	205 Participants n=99 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

Population: Safety Population 1 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant treatment period) and Safety Population 2 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period).

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 Participants Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Number of Participants With Adverse Events (AEs)	130 Participants	94 Participants

PRIMARY outcome

Timeframe: Up to approximately 28 weeks

Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 Participants Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Erythrocytes, Hematology (10^12/L): < 0.9 * LLN	3 participants	3 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Hematocrit (fraction of 1): < 0.9 * LLN	5 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Hemoglobin (g/L): < 0.9 * LLN	6 participants	3 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Leukocytes, Hematology (10^9/L): < 0.9 * LLN	3 participants	7 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Lymphocytes (10^9/L): < 0.7 * LLN	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Lymphocytes (10^9/L): > 1.3 * ULN	0 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Neutrophils (10^9/L): < 0.7 * LLN	4 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Neutrophils (10^9/L): > 1.3 * ULN	4 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Platelets (10^9/L): < 0.5 * LLN	0 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Alanine Aminotransferase (U/L): ≥ 3.0 * ULN	3 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Aspartate Aminotransferase (U/L): ≥ 3.0 * ULN	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Bicarbonate (mmol/L): < 0.9 * LLN	5 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Bilirubin, Chemistry (µmol/L): ≥ 1.5 * ULN	2 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Calcium (mmol/L): < 0.9 * LLN	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Creatine Kinase (U/L): > 2.0 * ULN	9 participants	5 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glucose, Chemistry (mmol/L): < 0.8 * LLN	2 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glucose, Chemistry (mmol/L): > 2.0 * ULN	2 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Lactate Dehydrogenase (U/L): > 3.0 * ULN	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Phosphate (mmol/L): < 0.9 * LLN	1 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Phosphate (mmol/L): > 1.1 * ULN	3 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Potassium (mmol/L): < 0.9 * LLN	0 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Potassium (mmol/L): > 1.1 * ULN	5 participants	4 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Protein, Chemistry (g/L): < 0.9 * LLN	3 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glucose, Urinalysis: At least 1+	4 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Protein, Urinalysis: At least 1+	38 participants	39 participants

PRIMARY outcome

Timeframe: Up to approximately 24 weeks

12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 Participants Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator PR Interval (msec): ≥ 250	0 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QRS Interval (msec): ≥ 150	0 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcB (msec): > 500	0 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcB (msec): Increase of > 60	0 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF (msec): > 500	0 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF (msec): Increase of > 60	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to approximately 28 weeks

PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 Participants Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Systolic Blood Pressure (mmHg): ≤ 90 and Decrease of ≥ 20	4 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Systolic Blood Pressure (mmHg): ≥ 180 and Increase of ≥ 20	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Systolic Blood Pressure (mmHg): ≤ 90 and Decrease of ≥ 20	2 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Diastolic Blood Pressure (mmHg): ≥ 105 and Increase of ≥ 15	1 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Diastolic Blood Pressure (mmHg): ≥ 105 and Increase of ≥ 15	5 participants	3 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Diastolic Blood Pressure (mmHg): ≤ 50 and Decrease of ≥ 15	1 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Pulse Rate (bpm): ≥ 120 and Increase of ≥ 15	0 participants	1 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Pulse Rate (bpm): ≤ 50 and Decrease of ≥ 15	4 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Pulse Rate (bpm): ≥ 120 and Increase of ≥ 15	1 participants	2 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing Pulse Rate (bpm): ≤ 50 and Decrease of ≥ 15	1 participants	0 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Increase of ≥ 7%	5 participants	7 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Decrease of ≥ 7%	16 participants	28 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Orthostatic Systolic Blood Pressure (mmHg): ≤ -20	12 participants	7 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Orthostatic Diastolic Blood Pressure (mmHg): ≤ -15	6 participants	10 participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Orthostatic Pulse Rate (bpm): ≥ 25	10 participants	7 participants

PRIMARY outcome

Timeframe: Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2

Population: Safety Population 1 consisted of all subjects who received at least 1 dose of study drug during the open-label atogepant treatment period as well as Safety Population 2 consisted of all subjects who went on to receive at least 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period. The one subject with positive suicidal behavior was erroneously reported in the questionnaire and had not had a positive suicidal behavior throughout the study.

C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 Participants Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Suicidal Ideation	0 participants	2 participants
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Suicidal Behavior	0 participants	1 participants

PRIMARY outcome

Timeframe: From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days.

Population: Safety Population 1 consisted of all subjects who received at least 1 dose of study drug during the open-label atogepant treatment period. The statistical analysis plan (SAP) does not include the Safety Population 2 (all subjects who received at least 1 dose of study drug in Period 2) subgroup analyses for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg (Period 1) n=262 Participants Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period Suicidal Ideation During Follow-Up Period	1 participants	—
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period Suicidal Behavior During Follow-Up Period	0 participants	—

Adverse Events

Atogepant 60 mg (Period 1)

Serious events: 1 serious events

Other events: 66 other events

Deaths: 0 deaths

Atogepant 60 mg + Ubrogepant 100 mg (Period 2)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atogepant 60 mg (Period 1) n=263 participants at risk Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 participants at risk Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Nervous system disorders MYELOPATHY	0.00% 0/263 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	0.46% 1/218 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
Renal and urinary disorders URETEROLITHIASIS	0.38% 1/263 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	0.00% 0/218 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.

Other adverse events

Other adverse events
Measure	Atogepant 60 mg (Period 1) n=263 participants at risk Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1.	Atogepant 60 mg + Ubrogepant 100 mg (Period 2) n=218 participants at risk Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
Gastrointestinal disorders CONSTIPATION	5.3% 14/263 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	0.92% 2/218 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
Gastrointestinal disorders NAUSEA	6.1% 16/263 • Number of events 16 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	0.92% 2/218 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
General disorders FATIGUE	6.5% 17/263 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	1.4% 3/218 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
Infections and infestations COVID-19	8.7% 23/263 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	3.2% 7/218 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
Metabolism and nutrition disorders DECREASED APPETITE	5.7% 15/263 • Number of events 15 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.	0.92% 2/218 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER