Trial Outcomes & Findings for Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (NCT NCT03939312)

Last Updated: 2022-05-12

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

685 participants

Primary outcome timeframe

From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)

Results posted on

2022-05-12

Participant Flow

Participants rolled over from the lead-in study 3101-301-002 (NCT03777059) into this extension study. This study consisted of two periods: Open-label (OL) Treatment Period and Safety Follow-up Period.

Participant milestones

Participant milestones
Measure	Atogepant 60 mg Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
OL Treatment Period (40 Weeks) STARTED	685
OL Treatment Period (40 Weeks) COMPLETED	511
OL Treatment Period (40 Weeks) NOT COMPLETED	174
Safety Follow-up 4 Weeks (Up to Week 44) STARTED	640
Safety Follow-up 4 Weeks (Up to Week 44) COMPLETED	624
Safety Follow-up 4 Weeks (Up to Week 44) NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Atogepant 60 mg Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
OL Treatment Period (40 Weeks) Withdrawal Criteria at Visit 1	43
OL Treatment Period (40 Weeks) Adverse Event	25
OL Treatment Period (40 Weeks) Lack of Efficacy	4
OL Treatment Period (40 Weeks) Withdrawal by Subject	35
OL Treatment Period (40 Weeks) Lost to Follow-up	19
OL Treatment Period (40 Weeks) Pregnancy	3
OL Treatment Period (40 Weeks) Protocol Deviation	16
OL Treatment Period (40 Weeks) Non-compliance With Study Drug	4
OL Treatment Period (40 Weeks) Site Terminated by Sponsor	3
OL Treatment Period (40 Weeks) Reason Not Specified	22
Safety Follow-up 4 Weeks (Up to Week 44) Withdrawal by Subject	12
Safety Follow-up 4 Weeks (Up to Week 44) Lost to Follow-up	4

Baseline Characteristics

Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atogepant 60 mg n=685 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
Age, Continuous	41.8 years STANDARD_DEVIATION 12.30 • n=99 Participants
Sex: Female, Male Female	604 Participants n=99 Participants
Sex: Female, Male Male	81 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	631 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants
Race (NIH/OMB) Asian	9 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	86 Participants n=99 Participants
Race (NIH/OMB) White	578 Participants n=99 Participants
Race (NIH/OMB) More than one race	8 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)

Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study.

Outcome measures

Outcome measures
Measure	Atogepant 60 mg n=685 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.	Safety Follow-up Period Following the open-label treatment period, participants entered the 4-week safety follow-up period.
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) TEAEs	62.5 percentage of participants	—
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) TESAEs	3.4 percentage of participants	—

SECONDARY outcome

Timeframe: Up to Week 44

Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study. Number analyzed are participants with data available for analyses of the specific category.

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 n=685 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.	Safety Follow-up Period Following the open-label treatment period, participants entered the 4-week safety follow-up period.
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Eosinophils Absolute Cell Count (10^9/L): > 2.0 × Upper Limit of Normal (ULN)	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Hematocrit (Ratio): < 0.9 × Lower Limit of Normal (LLN)	1.5 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Hematocrit (Ratio): > 1.1 × ULN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Hemoglobin (g/L): < 0.9 × LLN	2.2 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Lymphocytes Absolute Cell Count (10^9/L): < 0.7 × LLN	0.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Lymphocytes Absolute Cell Count (10^9/L): > 1.3 × ULN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Monocytes Absolute Cell Count (10^9/L): < 0.5 × LLN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Neutrophils Absolute Cell Count (10^9/L): < 0.7 × LLN	1.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Neutrophils Absolute Cell Count (10^9/L): > 1.3 × ULN	4.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Platelet Count (Thrombocytes) (10^9/L): < 0.5 × LLN	0.1 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Platelet Count (Thrombocytes) (10^9/L): > 1.5 × ULN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Red Blood Cell Count (10^12/L): < 0.9 × LLN	2.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Red Blood Cell Count (10^12/L): > 1.1 × ULN	0.1 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator White Blood Cell Count (10^9/L): < 0.9 × LLN	3.5 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator White Blood Cell Count (10^9/L): > 1.5 × ULN	0.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Alanine Aminotransferase (SGPT) (U/L): ≥ 3.0 × ULN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Aspartate Aminotransferase (SGOT) (U/L): ≥ 3.0 × ULN	0.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Bicarbonate (HCO3) (mmol/L): < 0.9 × LLN	0.7 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Bilirubin, Total (umol/L): ≥ 1.5 × ULN	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Blood Urea Nitrogen (mmol/L): > 1.5 × ULN	0.1 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Creatine Kinase (U/L): > 2.0 × ULN	5.0 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Creatinine (umol/L): > 1.5 × ULN	0.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glomerular Filtration Rate (GFR) Estimated Calculation (mL/min/1.73m^2): < 60 mL/min/1.73m^2	15.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glucose, Non-fasting (mmol/L): < 0.8 × LLN	2.2 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Glucose, Non-fasting (mmol/L): > 2.0 × ULN	0.9 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Phosphorus (mmol/L): < 0.9 × LLN	1.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Phosphorus (mmol/L): > 1.1 × ULN	0.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Potassium (mmol/L): > 1.1 × ULN	2.2 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Protein, Total (g/L): < 0.9 × LLN	0.7 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Uric Acid (Urate) (umol/L): > 1.2 × ULN	0.7 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Urine Glucose: At Least 1+	0.9 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Urine Protein: At Least 1+	27.6 percentage of participants	—

SECONDARY outcome

Timeframe: Up to Week 40

Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study.

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 n=665 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.	Safety Follow-up Period Following the open-label treatment period, participants entered the 4-week safety follow-up period.
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QRS Duration, Single Beat (msec): ≥ 150 milliseconds (msecs)	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator PR interval, Single Beat (msec): ≥ 250 msecs	0.5 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcB interval, Single Beat (msec): > 500 msecs	0.2 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcB interval, Single Beat (msec): Increase > 60 msecs	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF interval, Single Beat (msec): Increase > 60 msecs	0.2 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF interval, Single Beat (msec): >450 msecs	3.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF interval, Single Beat (msec): >480 msecs	0.1 percentage of participants	—

SECONDARY outcome

Timeframe: Up to Week 44

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 n=685 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.	Safety Follow-up Period Following the open-label treatment period, participants entered the 4-week safety follow-up period.
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing - Sitting Pulse Rate (beats/min): ≥ 25	6.8 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Systolic Blood Pressure Sitting (mmHg): ≤ 90 and Decrease of ≥ 20	1.9 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Systolic Blood Pressure Standing (mmHg): ≤ 90 and Decrease of ≥ 20	0.7 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Systolic Blood Pressure Standing (mmHg): ≥ 180 and Increase of ≥ 20	0.1 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing - Sitting Systolic Blood Pressure (mmHg): ≤ -20	9.8 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Diastolic Blood Pressure Sitting (mmHg): ≤ 50 and Decrease of ≥ 15	0.6 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Diastolic Blood Pressure Sitting (mmHg): ≥ 105 and Increase of ≥ 15	1.0 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Diastolic Blood Pressure Standing (mmHg): ≤ 50 and Decrease of ≥ 15	0.7 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Diastolic Blood Pressure Standing (mmHg): ≥ 105 and Increase of ≥ 15	1.5 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Standing - Sitting Diastolic Blood Pressure (mmHg): ≤ -15	7.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Pulse Rate Sitting (beats/min): ≤ 50 and Decrease of ≥ 15	0.3 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Pulse Rate Standing (beats/min): ≤ 50 and Decrease of ≥ 15	0.4 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Pulse Rate Standing (beats/min): ≥ 120 and Increase of ≥ 15	1.8 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Decrease of ≥ 7 percent (%)	23.9 percentage of participants	—
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Increase of ≥ 7%	9.2 percentage of participants	—

SECONDARY outcome

Timeframe: OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44

Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study. One Safety population was used for the entire study. If participants were eligible for the Safety Follow-up they were included in the analyses even if they did not participate in the Safety Follow-up Period.

C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and 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 n=685 Participants Participants received atogepant 60 mg, orally, QD for up to 40 weeks.	Safety Follow-up Period n=685 Participants Following the open-label treatment period, participants entered the 4-week safety follow-up period.
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation	4 Participants	1 Participants
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Behavior	0 Participants	0 Participants

Adverse Events

Atogepant 60 mg

Serious events: 23 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atogepant 60 mg n=685 participants at risk Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
Gastrointestinal disorders Gastritis	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
General disorders Non-cardiac chest pain	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
General disorders Systemic inflammatory response syndrome	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Hepatobiliary disorders Cholelithiasis	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Infections and infestations Clostridium difficile colitis	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Infections and infestations Corona virus infection	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Infections and infestations Staphylococcal infection	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Road traffic accident	0.29% 2/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Concussion	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Craniocerebral injury	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Fall	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Overdose	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Procedural pain	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Injury, poisoning and procedural complications Subdural haematoma	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.58% 4/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Nervous system disorders Multiple sclerosis	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Nervous system disorders Subarachnoid haemorrhage	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.29% 2/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Renal and urinary disorders Ureterolithiasis	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Social circumstances Victim of abuse	0.15% 1/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)

Other adverse events

Other adverse events
Measure	Atogepant 60 mg n=685 participants at risk Participants received atogepant 60 mg, orally, QD for up to 40 weeks.
Infections and infestations Upper respiratory tract infection	5.5% 38/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Infections and infestations Urinary tract infection	5.3% 36/685 • From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)

Additional Information

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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