Trial Outcomes & Findings for A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood (NCT NCT05147662)
NCT ID: NCT05147662
Last Updated: 2025-12-31
Results Overview
The occurrence of the defined adverse events of special interest was documented during the first 4 days that a participant was exposed to the study intervention.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Individual first 4 exposure days
Results posted on
2025-12-31
Participant Flow
The study was conducted at 17 study centers in 7 countries between 23-Mar-2022 (first participant consent) and 04-Jan-2024 (last participant last visit in study part A).
Overall, 40 participants were screened. Of the 40 screened participants, 3 (7.5%) failed screening and 1 (2.5%) was not enrolled for other reasons. 36 (90%) participants were assigned to treatment and 35 (88%) participants received study treatment. These initial results comprise a 6-month treatment phase (Part A) with a minimum of 50 exposure days. Evaluation of results for the subsequent 18-month extension (Part B) is ongoing. These results will be reported as part of the final results.
Participant milestones
| Measure |
All Participants
All participants
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Treated
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Participants
All participants
|
|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
3
|
|
Overall Study
Assigned to treatment but never treated
|
1
|
Baseline Characteristics
A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood
Baseline characteristics by cohort
| Measure |
All Participants
n=35 Participants
All participants
|
|---|---|
|
Age, Continuous
|
8.63 Years
STANDARD_DEVIATION 1.37 • n=1000 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1000 Participants
|
PRIMARY outcome
Timeframe: Individual first 4 exposure daysPopulation: The primary endpoint analysis was performed on the modified safety analysis set (n=34). One participant in the safety analysis set (which consisted of all participants enrolled into part A of the study who had taken at least 1 dose of the study intervention; n=35) was excluded from the primary endpoint assessment due to treatment discontinuation for any reason other than AESI before the 4th ED.
The occurrence of the defined adverse events of special interest was documented during the first 4 days that a participant was exposed to the study intervention.
Outcome measures
| Measure |
All Participants
n=34 Participants
All participants
|
|---|---|
|
Adverse Events of Special Interest (AESI) Hypersensitivity and Loss of Efficacy Associated With the First 4 Exposure Days (EDs) Leading to Discontinuation
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsAdverse drug reactions were defined as any adverse events where a causal relationship of at least possibly related with the use of BAY 94-9027 had been ascribed by the investigator. In this study, treatment emergent study drug-related adverse events were used in defining ADRs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsAll participants were tested for the development of anti-drug antibodies (ADAs) (anti-polyethylene glycol \[PEG\] and anti-PEG immunoglobulin M \[IgM\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsA positive FVIII inhibitor test was defined with a threshold of ≥ 0.6 BU/mL at the central laboratory. The first positive measurement was confirmed by a second, different sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsFor each participant, the number of bleeds was related to the individual observation period to assess bleeding rates. For descriptive analyses, bleeding rates were annualized at the individual participant level using the formula: ABR = (number of bleeds × 365.25 × 24 × 60)/(Period). Period was defined as the number of minutes calculated from the date and time of the beginning of the treatment period and the date and time of the end of the treatment period of interest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsSummary statistics for BAY 94-9027 consumption are provided for prophylaxis treatment, for treatment of bleeds, and overall. Consumption per year and per infusion is presented based on total dose (IU) and dose per body weight (IU/kg).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsNumber of infusions per month and year
Outcome measures
Outcome data not reported
Adverse Events
Prophylaxis
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prophylaxis
n=35 participants at risk
Prophylaxis
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
Other adverse events
| Measure |
Prophylaxis
n=35 participants at risk
Prophylaxis
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Injection site pruritus
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Pyrexia
|
8.6%
3/35 • Number of events 3 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Eye disorders
Conjunctivitis allergic
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Eye disorders
Eye irritation
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Gastrointestinal disorders
Dental caries
|
2.9%
1/35 • Number of events 2 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Gastrointestinal disorders
Odynophagia
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Drug ineffective
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Injection site rash
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Peripheral swelling
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
General disorders
Infusion site pain
|
2.9%
1/35 • Number of events 3 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Immune system disorders
Hypersensitivity
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Immune system disorders
Seasonal allergy
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Conjunctivitis viral
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Ear infection
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Influenza
|
8.6%
3/35 • Number of events 3 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • Number of events 2 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Otitis externa
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Paronychia
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Sinusitis
|
5.7%
2/35 • Number of events 2 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Tonsillitis
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Viral infection
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Viral pharyngitis
|
5.7%
2/35 • Number of events 2 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Periorbital cellulitis
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Infections and infestations
Pneumonia bacterial
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Face injury
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Lip injury
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Investigations
Respiratory sinus arrhythmia magnitude
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 2 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 5 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 5 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.9%
1/35 • Number of events 1 • From start of study intervention up to 26 weeks, with a mean and median duration of study intervention of 182 days at the time of interim analysis.
Adverse event reporting for all-cause mortality considers all deaths that occurred at any time during the study before the last contact for interim analysis, from up to 30 days before start of study intervention until a mean and median duration on study intervention of 182 days at the time of these interim results, for a mean total of 182-212 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications before submission for publication and embargo such communications for 45 days. If confidential information is present, the sponsor can embargo proposed publications for an additional 75 days to seek protection of intellectual property. For multi-center studies, publication of results specific to the PI's institution can be embargoed for as long as a multi-center publication is not published, up to a maximum of 18 months.
- Publication restrictions are in place
Restriction type: OTHER