Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (NCT NCT02867709)
NCT ID: NCT02867709
Last Updated: 2019-03-19
Results Overview
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
COMPLETED
PHASE3
1686 participants
Baseline (Predose) to 2 hours after initial dose
2019-03-19
Participant Flow
Participant milestones
| Measure |
Placebo
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
563
|
561
|
562
|
|
Treatment Period
Safety Population: Received Study Drug
|
499
|
478
|
488
|
|
Treatment Period
COMPLETED
|
493
|
474
|
487
|
|
Treatment Period
NOT COMPLETED
|
70
|
87
|
75
|
|
Safety Follow-up Period
STARTED
|
493
|
474
|
487
|
|
Safety Follow-up Period
COMPLETED
|
482
|
459
|
473
|
|
Safety Follow-up Period
NOT COMPLETED
|
11
|
15
|
14
|
Reasons for withdrawal
| Measure |
Placebo
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
1
|
2
|
|
Treatment Period
Withdrawal of Consent
|
7
|
9
|
8
|
|
Treatment Period
Lost to Follow-up
|
17
|
20
|
20
|
|
Treatment Period
Lack of Qualifying Event
|
42
|
55
|
42
|
|
Treatment Period
Protocol Violation
|
3
|
2
|
3
|
|
Safety Follow-up Period
Withdrawal of Consent
|
1
|
8
|
6
|
|
Safety Follow-up Period
Lost to Follow-up
|
10
|
5
|
7
|
|
Safety Follow-up Period
Pregnancy
|
0
|
1
|
0
|
|
Safety Follow-up Period
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=563 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=561 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=562 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Total
n=1686 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
41.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=5 Participants
|
501 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
1492 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
449 Participants
n=5 Participants
|
467 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
1372 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
94 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
116 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
370 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
447 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
1316 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Predose) to 2 hours after initial dosePopulation: Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=435 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=464 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
|
14.3 percentage of participants
|
20.7 percentage of participants
|
21.8 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Predose) to 2 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded baseline migraine headache severity measurement, had ≥1 postdose migraine headache severity/migraine-associated symptom measurement at/before 2-hour timepoint, LOCF. Number analyzed is participants with data available for analysis.
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=434 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=463 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
|
27.4 percentage of participants
|
34.1 percentage of participants
|
38.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Predose) to 2 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.
Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=435 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=464 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
|
48.2 percentage of participants
|
60.5 percentage of participants
|
62.7 percentage of participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.
Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=443 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=424 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=449 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
|
21.0 percentage of participants
|
32.5 percentage of participants
|
36.7 percentage of participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=451 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=432 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=457 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
|
8.2 percentage of participants
|
12.7 percentage of participants
|
14.4 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.
Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=435 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=464 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
|
35.5 percentage of participants
|
39.3 percentage of participants
|
43.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=435 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=464 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
|
46.3 percentage of participants
|
53.6 percentage of participants
|
54.1 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours after initial dosePopulation: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.
Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.
Outcome measures
| Measure |
Placebo
n=456 Participants
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=435 Participants
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=464 Participants
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
|
70.0 percentage of participants
|
70.6 percentage of participants
|
71.3 percentage of participants
|
Adverse Events
Placebo
Ubrogepant 25 mg
Ubrogepant 50 mg
Serious adverse events
| Measure |
Placebo
n=499 participants at risk
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 25 mg
n=478 participants at risk
1 ubrogepant 25 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
Ubrogepant 50 mg
n=488 participants at risk
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/499 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.21%
1/478 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/488 • From first dose through 30 days after the last dose of study drug (approximately 30 days)
Safety population, all participants who received at least 1 dose of investigational product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER