Trial Outcomes & Findings for A Study of LY2951742 in Participants With Migraine (NCT NCT01625988)
NCT ID: NCT01625988
Last Updated: 2020-01-09
Results Overview
The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2020-01-09
Participant Flow
Participant milestones
| Measure |
LY2951742
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
110
|
|
Overall Study
Received at Least One Dose of Study Drug
|
107
|
110
|
|
Overall Study
COMPLETED
|
94
|
97
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
LY2951742
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Randomized Inappropriately
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
All participants who received at least one dose of study drug and had baseline Age data.
Baseline characteristics by cohort
| Measure |
LY2951742
n=107 Participants
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
n=110 Participants
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 11.4 • n=107 Participants • All participants who received at least one dose of study drug and had baseline Age data.
|
41.9 years
STANDARD_DEVIATION 11.7 • n=109 Participants • All participants who received at least one dose of study drug and had baseline Age data.
|
41.4 years
STANDARD_DEVIATION 11.5 • n=216 Participants • All participants who received at least one dose of study drug and had baseline Age data.
|
|
Sex: Female, Male
Female
|
88 Participants
n=107 Participants
|
96 Participants
n=110 Participants
|
184 Participants
n=217 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=107 Participants
|
14 Participants
n=110 Participants
|
33 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=107 Participants
|
13 Participants
n=110 Participants
|
24 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=107 Participants
|
97 Participants
n=110 Participants
|
193 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=110 Participants
|
0 Participants
n=217 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
1 Participants
n=110 Participants
|
1 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=107 Participants
|
26 Participants
n=110 Participants
|
51 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=107 Participants
|
2 Participants
n=110 Participants
|
4 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
2 Participants
n=110 Participants
|
2 Participants
n=217 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=107 Participants
|
74 Participants
n=110 Participants
|
150 Participants
n=217 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=107 Participants
|
2 Participants
n=110 Participants
|
4 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=107 Participants
|
3 Participants
n=110 Participants
|
5 Participants
n=217 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=107 Participants
|
110 participants
n=110 Participants
|
217 participants
n=217 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Outcome measures
| Measure |
LY2951742
n=106 Participants
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
n=110 Participants
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase
|
-4.2 Migraine headache days
Standard Error 0.30
|
-3.0 Migraine headache days
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Outcome measures
| Measure |
LY2951742
n=106 Participants
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
n=110 Participants
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase
|
-4.9 Headache days
Standard Error 0.40
|
-3.7 Headache days
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Outcome measures
| Measure |
LY2951742
n=106 Participants
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
n=110 Participants
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase
|
-3.1 Migraine attacks
Standard Error 0.23
|
-2.3 Migraine attacks
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, and 12 weeksPopulation: All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.
Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Outcome measures
| Measure |
LY2951742
n=107 Participants
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo
n=110 Participants
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
|---|---|---|
|
Percentage of Responders
Week 4
|
57.9 Percentage of participants
|
37.3 Percentage of participants
|
|
Percentage of Responders
Week 8
|
61.7 Percentage of participants
|
42.7 Percentage of participants
|
|
Percentage of Responders
Week 12
|
64.5 Percentage of participants
|
42.7 Percentage of participants
|
Adverse Events
LY2951742 Treatment Period
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo Treatment Period
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
LY2951742 Posttreatment Period
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Posttreatment Period
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2951742 Treatment Period
n=107 participants at risk
LY2951742: 150 mg, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo Treatment Period
n=110 participants at risk
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
LY2951742 Posttreatment Period
n=98 participants at risk
LY2951742: The LY2951742 posttreatment period reporting group includes participants who received 150 mg LY2951742, completed the 12-week treatment period, and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
|
Placebo Posttreatment Period
n=103 participants at risk
Placebo: The Placebo posttreatment period reporting group includes participants who received 0.9% Sodium Chloride, USP; completed the 12-week treatment period; and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.91%
1/110 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/103
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/88
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/96
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.2%
1/80 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/88
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/96
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/80
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/90 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/107
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/110
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/103
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
LY2951742 Treatment Period
n=107 participants at risk
LY2951742: 150 mg, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
Placebo Treatment Period
n=110 participants at risk
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
|
LY2951742 Posttreatment Period
n=98 participants at risk
LY2951742: The LY2951742 posttreatment period reporting group includes participants who received 150 mg LY2951742, completed the 12-week treatment period, and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
|
Placebo Posttreatment Period
n=103 participants at risk
Placebo: The Placebo posttreatment period reporting group includes participants who received 0.9% Sodium Chloride, USP; completed the 12-week treatment period; and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
13/107 • Number of events 16
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.1%
10/110 • Number of events 11
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.1%
4/98 • Number of events 5
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/103
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
4/107 • Number of events 4
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.5%
6/110 • Number of events 8
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
4/107 • Number of events 4
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.2%
9/110 • Number of events 10
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.97%
1/103 • Number of events 1
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injection site pain
|
16.8%
18/107 • Number of events 65
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.4%
7/110 • Number of events 14
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/103
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
7/107 • Number of events 7
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.3%
8/110 • Number of events 8
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/103
All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
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Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Arteaus Therapeutics executed the contracts and trial, and the Principal Investigators are restricted by any original contractual disclosure restrictions or agreements with Arteaus Therapeutics.
- Publication restrictions are in place
Restriction type: OTHER