Trial Outcomes & Findings for Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients (NCT NCT03333109)
NCT ID: NCT03333109
Last Updated: 2021-10-11
Results Overview
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
900 participants
Primary outcome timeframe
Baseline up to Month 3
Results posted on
2021-10-11
Participant Flow
Participant milestones
| Measure |
AMG334 70 mg
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Double-blind Treatment Period (DBTP)
STARTED
|
338
|
224
|
338
|
|
Double-blind Treatment Period (DBTP)
Full Analysis Set
|
329
|
219
|
330
|
|
Double-blind Treatment Period (DBTP)
Safety Analysis Set
|
335
|
224
|
335
|
|
Double-blind Treatment Period (DBTP)
COMPLETED
|
321
|
218
|
326
|
|
Double-blind Treatment Period (DBTP)
NOT COMPLETED
|
17
|
6
|
12
|
|
Safety Follow-up Period
STARTED
|
324
|
218
|
328
|
|
Safety Follow-up Period
COMPLETED
|
311
|
214
|
315
|
|
Safety Follow-up Period
NOT COMPLETED
|
13
|
4
|
13
|
Reasons for withdrawal
| Measure |
AMG334 70 mg
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Double-blind Treatment Period (DBTP)
Adverse Event
|
0
|
0
|
2
|
|
Double-blind Treatment Period (DBTP)
Lost to Follow-up
|
0
|
0
|
1
|
|
Double-blind Treatment Period (DBTP)
Physician Decision
|
4
|
0
|
1
|
|
Double-blind Treatment Period (DBTP)
Pregnancy
|
1
|
0
|
0
|
|
Double-blind Treatment Period (DBTP)
Withdrawal by Subject
|
9
|
6
|
5
|
|
Double-blind Treatment Period (DBTP)
Randomized but not treated
|
3
|
0
|
3
|
|
Safety Follow-up Period
Lost to Follow-up
|
6
|
2
|
1
|
|
Safety Follow-up Period
Withdrawal by Subject
|
7
|
2
|
12
|
Baseline Characteristics
This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm
Baseline characteristics by cohort
| Measure |
AMG334 70 mg
n=338 Participants
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
n=224 Participants
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=338 Participants
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 10.0 • n=338 Participants
|
37.1 years
STANDARD_DEVIATION 9.6 • n=224 Participants
|
38.0 years
STANDARD_DEVIATION 10.1 • n=338 Participants
|
37.5 years
STANDARD_DEVIATION 9.9 • n=900 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=338 Participants
|
184 Participants
n=224 Participants
|
281 Participants
n=338 Participants
|
737 Participants
n=900 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=338 Participants
|
40 Participants
n=224 Participants
|
57 Participants
n=338 Participants
|
163 Participants
n=900 Participants
|
|
Race/Ethnicity, Customized
White
|
58 participants
n=338 Participants
|
35 participants
n=224 Participants
|
60 participants
n=338 Participants
|
153 participants
n=900 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=338 Participants
|
0 participants
n=224 Participants
|
0 participants
n=338 Participants
|
1 participants
n=900 Participants
|
|
Race/Ethnicity, Customized
Asian
|
278 participants
n=338 Participants
|
184 participants
n=224 Participants
|
269 participants
n=338 Participants
|
731 participants
n=900 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=338 Participants
|
0 participants
n=224 Participants
|
1 participants
n=338 Participants
|
2 participants
n=900 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
9 participants
n=338 Participants
|
8 participants
n=224 Participants
|
5 participants
n=338 Participants
|
22 participants
n=900 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=338 Participants
|
13 participants
n=224 Participants
|
13 participants
n=338 Participants
|
35 participants
n=900 Participants
|
|
Monthly Migraine Days at Baseline
|
8.09 Migraine days/month
STANDARD_DEVIATION 2.62 • n=337 Participants • This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm
|
8.27 Migraine days/month
STANDARD_DEVIATION 3.14 • n=224 Participants • This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm
|
8.35 Migraine days/month
STANDARD_DEVIATION 2.76 • n=338 Participants • This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm
|
8.23 Migraine days/month
STANDARD_DEVIATION 2.81 • n=899 Participants • This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm
|
PRIMARY outcome
Timeframe: Baseline up to Month 3Population: Full analysis set
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Outcome measures
| Measure |
AMG334 70 mg
n=329 Participants
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
n=219 Participants
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=330 Participants
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
|
-4.20 Migraine days/month
Standard Error 0.25
|
-4.79 Migraine days/month
Standard Error 0.30
|
-3.10 Migraine days/month
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline and at Month 3Population: Full analysis set
Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Outcome measures
| Measure |
AMG334 70 mg
n=329 Participants
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
n=219 Participants
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=330 Participants
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3
|
55.3 percentage of participants
|
63.9 percentage of participants
|
44.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Analysis set included participants with at least one acute migraine-specific medication use during baseline
Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.
Outcome measures
| Measure |
AMG334 70 mg
n=123 Participants
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
n=80 Participants
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=127 Participants
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3
|
-1.84 Migraine days/month
Standard Error 0.26
|
-2.39 Migraine days/month
Standard Error 0.33
|
-0.49 Migraine days/month
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline up to Month 3Population: Analysis included participants with a non-missing value at the corresponding time point of interest
The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme
Outcome measures
| Measure |
AMG334 70 mg
n=296 Participants
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG334 140 mg
n=200 Participants
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=308 Participants
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3
|
-8.39 scores on a scale
Standard Error 0.45
|
-9.34 scores on a scale
Standard Error 0.54
|
-6.62 scores on a scale
Standard Error 0.44
|
Adverse Events
AMG 334 70mg
Serious events: 10 serious events
Other events: 83 other events
Deaths: 0 deaths
AMG 334 140mg
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 334 70mg
n=335 participants at risk
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG 334 140mg
n=224 participants at risk
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=335 participants at risk
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
General disorders
Asthenia
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Labyrinthitis
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Nervous system disorders
Migraine
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Psychiatric disorders
Depression
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
Other adverse events
| Measure |
AMG 334 70mg
n=335 participants at risk
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
|
AMG 334 140mg
n=224 participants at risk
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Placebo
n=335 participants at risk
Two pre-filled syringes containing placebo identical in appearance to erenumab
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.0%
20/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
5.4%
12/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
3.0%
10/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.8%
6/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.45%
1/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.90%
3/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.8%
6/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
General disorders
Fatigue
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
General disorders
Injection site erythema
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.45%
1/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
2.4%
8/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
General disorders
Injection site pain
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
General disorders
Pyrexia
|
3.3%
11/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
2.2%
5/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
5.7%
19/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Cystitis
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.8%
4/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Influenza
|
2.4%
8/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
4.0%
9/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
3.9%
13/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
13/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
2.7%
6/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
2.7%
9/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Investigations
Blood glucose increased
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.3%
3/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.30%
1/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Nervous system disorders
Dizziness
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
3.1%
7/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.8%
6/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Nervous system disorders
Migraine
|
1.8%
6/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.00%
0/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.90%
3/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.90%
3/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
2.2%
5/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
1.2%
4/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
5/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.89%
2/224 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
0.60%
2/335 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER