Trial Outcomes & Findings for Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine (NCT NCT03912337)
NCT ID: NCT03912337
Last Updated: 2022-07-20
Results Overview
The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome.
TERMINATED
PHASE4
29 participants
Baseline and Months 1 to 6
2022-07-20
Participant Flow
This study was conducted at 13 centers in the United States of America. The study consisted of a 4-week baseline period and a 6-month double-blind treatment period (DBTP).
Eligible participants were randomized in a 1:1 ratio to either erenumab 140 milligrams (mg) or placebo once monthly (QM).
Participant milestones
| Measure |
Placebo QM
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo QM
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Overall Study
Withdrawal of Consent From Study
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Baseline characteristics by cohort
| Measure |
Placebo QM
n=15 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=14 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Modified Migraine Disability Assessment (MIDAS) Total Score
|
20.3 score on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
23.1 score on a scale
STANDARD_DEVIATION 11.3 • n=7 Participants
|
21.7 score on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Monthly Migraine Days (MMD)
|
9.2 migraine days per month
STANDARD_DEVIATION 3.7 • n=5 Participants
|
9.0 migraine days per month
STANDARD_DEVIATION 2.8 • n=7 Participants
|
9.1 migraine days per month
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Monthly Percent Work Impairment
|
49.5 percentage of monthly workdays impaired
STANDARD_DEVIATION 19.0 • n=5 Participants
|
57.6 percentage of monthly workdays impaired
STANDARD_DEVIATION 13.5 • n=7 Participants
|
53.4 percentage of monthly workdays impaired
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Functioning Domain Score
|
46.5 score on a scale
STANDARD_DEVIATION 17.9 • n=5 Participants
|
56.8 score on a scale
STANDARD_DEVIATION 23.8 • n=7 Participants
|
51.5 score on a scale
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
MFIQ - Impact on Usual Activities Domain Score
|
38.5 score on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
51.3 score on a scale
STANDARD_DEVIATION 20.0 • n=7 Participants
|
44.7 score on a scale
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
MFIQ - Impact on Social Functioning Domain Score
|
41.8 score on a scale
STANDARD_DEVIATION 18.6 • n=5 Participants
|
54.2 score on a scale
STANDARD_DEVIATION 19.4 • n=7 Participants
|
47.8 score on a scale
STANDARD_DEVIATION 19.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 1 to 6Population: The respective efficacy analysis set (EAS) consisted of a subset of participants from traditional study sites or DCTS who received at least 1 dose of investigational product (IP) and had a baseline value and at least 1 post baseline value for the endpoint of interest. Participants were analyzed according to their randomized treatment, regardless of the treatment received.
The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome.
Outcome measures
| Measure |
Placebo QM
n=15 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=14 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP
|
-71.17 score on a scale
Standard Deviation 60.81
|
-98.03 score on a scale
Standard Deviation 71.04
|
SECONDARY outcome
Timeframe: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTPPopulation: The respective EAS including only participants with observed MMD data.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache) or received migraine-specific medication during aura. A qualified migraine headache was defined either as a migraine (≥30 minutes) with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase subtract the number of migraine days during the 4-week baseline phase. A negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Placebo QM
n=14 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=14 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP
|
-3.01 migraine days per month
Standard Deviation 2.51
|
-5.60 migraine days per month
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTPPopulation: The respective EAS including only participants with observed WPAI data.
Percent work impairment was calculated based on questions 2, 4 and 5 of the Work Productivity and Activity Impairment (WPAI) Migraine-Questionnaire and could range from 0% to 100%. The questionnaire was collected weekly. The monthly percent work impairment was equal to the arithmetic mean of the observed weekly percent work impairment over the monthly interval. Higher scores indicate greater impairment. Change from baseline in mean monthly percent work impairment was calculated as the average of monthly percent work impairment over the last 3 months (month 4, 5, and 6) of the 24-week double-blind treatment phase minus the baseline score. A negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Placebo QM
n=14 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=12 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP
|
-28.84 percentage of monthly workdays impaired
Standard Deviation 14.55
|
-31.72 percentage of monthly workdays impaired
Standard Deviation 16.00
|
SECONDARY outcome
Timeframe: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTPPopulation: The respective EAS including only participants with observed MFIQ data.
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on physical functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ physical functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ physical functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ physical functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Placebo QM
n=14 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=13 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
|
-22.44 score on a scale
Standard Deviation 18.62
|
-31.99 score on a scale
Standard Deviation 33.05
|
SECONDARY outcome
Timeframe: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTPPopulation: The respective EAS including only participants with observed MFIQ data.
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 10 items on the impact on usual activities domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ usual activities domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ usual activities domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ usual activities domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Placebo QM
n=14 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=13 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
|
-20.82 score on a scale
Standard Deviation 13.15
|
-30.77 score on a scale
Standard Deviation 25.50
|
SECONDARY outcome
Timeframe: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTPPopulation: The respective EAS including only participants with observed MFIQ data.
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on social functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ social functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ social functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ social functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Placebo QM
n=14 Participants
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=13 Participants
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
|
-30.51 score on a scale
Standard Deviation 21.15
|
-41.44 score on a scale
Standard Deviation 28.37
|
Adverse Events
Placebo QM
Erenumab 140 mg QM
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo QM
n=15 participants at risk
Participants randomized to receive placebo QM for 6 months during the DBTP.
|
Erenumab 140 mg QM
n=14 participants at risk
Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
General disorders
Cyst
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
Infected dermal cyst
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Nervous system disorders
Dizziness postural
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
14.3%
2/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
13.3%
2/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
0.00%
0/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/15 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
7.1%
1/14 • Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER