Trial Outcomes & Findings for Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy (NCT NCT05604170)
NCT ID: NCT05604170
Last Updated: 2025-10-01
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical study patient, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event was any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other event that requires scientific judgment.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Up to 150 Weeks
Results posted on
2025-10-01
Participant Flow
A total 117 participants entered the OLE phase and had received at least 1 dose of Ganaxolone (GNX). Of these 8 were previously in Study 1042-TCS-2001 and 109 were previously in Study 1042-TCS-3001 and met eligibility criteria for continued treatment.
Participants who completed Study 1042-TCS-2001 and 1042-TCS-3001 were enrolled in the Open-Label Extension (OLE) phase and the study was terminated prematurely due to Sponsor decision.
Participant milestones
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Early study termination by sponsor
|
77
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
Baseline characteristics by cohort
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Age, Continuous
|
16.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
An adverse event (AE) was any untoward medical occurrence in a clinical study patient, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event was any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other event that requires scientific judgment.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Withdrawals and Dose-Reductions Due to AEs
Any serious TEAE
|
21 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Withdrawals and Dose-Reductions Due to AEs
Any TEAE
|
79 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Withdrawals and Dose-Reductions Due to AEs
Withdrawals Due to AEs
|
6 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Withdrawals and Dose-Reductions Due to AEs
Dose-Reduction Due to AEs
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Vital parameters including heart rate, respiration rate, blood pressure, and body temperature were measured in seated position for at least 5 minutes.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Physical examinations included a full physical evaluation of body systems including: General appearance, head (eyes, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, genitourinary, musculoskeletal, endocrine/metabolic, hematologic/lymphatic, skin, and other systems as appropriate.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examinations
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Neurological examinations included an evaluation of: Cranial nerves, motor exam, sensory exam, reflexes, coordination/cerebellar
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Neurological Examinations
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set. Only pediatric participants of 1 to 17 years of age were analyzed.
Developmental examinations (applicable only to pediatric participants 1 to 17 years of age, inclusive) included an evaluation of speech/language, motor skills, and social skills
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=72 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Developmental Examinations
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Twelve-lead ECGs were performed by the physician using an ECG machine that automatically calculates the heart rate and measure PR, QRS, QT and QTc intervals.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 1 through Week 150Population: Safety Analysis Set
Blood samples were collected for the analysis of hematology parameters: hemoglobin, hematocrit, erythrocytes, thrombocytes (platelet count). Differential blood counts, including basophils, eosinophils, neutrophils, lymphocytes, and monocytes
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Blood samples were collected for the analysis of chemistry parameters: blood urea nitrogen (BUN), potassium, alanine aminotransferase (ALT), alkaline phosphatase (ALP)/serum glutamic pyruvic transaminase (SGPT), total bilirubin, creatinine, sodium, aspartate aminotransferase (AST)/serum glutamic oxaloacetic (SGOT), total protein, fasting blood glucose, calcium, carbon dioxide, estimated glomerular filtration rate (eGFR), and chloride
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 150 WeeksPopulation: Safety Analysis Set
Urine samples were collected for the analysis of urinalysis parameters: Specific gravity, color, clarity, pH, glucose, protein, blood, nitrite, protein, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick, and microscopic examination (if blood or protein was abnormal)
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: Safety Analysis Set. Only those participants with data available at specified timepoints have been analyzed
The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported. The score ranges from 1 to 5 and higher scores indicate worse symptoms.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=45 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Preparatory acts or behavior
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Aborted attempt
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Interrupted attempt
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Actual attempt
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Completed suicide
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Wish to be dead
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Non-specific Active thoughts
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Active ideation without intention to act
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Active ideation with some intent to act without a plan
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Active ideation with a specific plan and intent
|
0 Participants
|
|
Number of Participants (Age Greater Than 17 Years) With Abnormal Columbia-Suicide Severity Rating Scale (C-SSRS)
Non-suicidal Self-Injurious Behavior
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 52Population: Intent to Treat comprised all participants who received at least 1 dose of the IP. Only those participants with data available at specified timepoints have been analyzed.
Seizure frequency will be calculated as the total number of seizures divided by the number of days with seizure data, multiplied by 28. Percent change from baseline in 28-day frequency was calculated for each participant by subtracting Baseline 28-day seizure frequency from post-Baseline 28-day seizure frequency, whole divided by Baseline 28-day seizure frequency and multiplied by 100.
Outcome measures
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=107 Participants
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Percent Change From Baseline in 28-day Seizure Frequency During Open Label Extension
|
-31.59 percent change
Standard Deviation 113.997
|
Adverse Events
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
Serious events: 21 serious events
Other events: 79 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 participants at risk
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Atypical Pneumonia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Bronchitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Covid-19
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Laryngitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Wound Infection
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Seizure
|
4.3%
5/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Status Epilepticus
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Pyrexia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Sudden Unexplained Death In Epilepsy
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Inappropriate Affect
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Mental Status Changes
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Product Issues
Embedded Device
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Renal and urinary disorders
Urethral Haemorrhage
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Renal and urinary disorders
Urethral Prolapse
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
Other adverse events
| Measure |
Ganaxolone (GNX) Oral Suspension, 3 Times a Day (TID)
n=117 participants at risk
Participants received 50 mg/mL oral suspension containing 110 mL Ganaxolone (GNX), 3 times a day (TID) with food.
|
|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.5%
10/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Pneumonia
|
5.1%
6/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
7/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Covid-19
|
3.4%
4/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Ear Infection
|
3.4%
4/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Influenza
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Tonsillitis
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Acarodermatitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Cellulitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Conjunctivitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Gastroenteritis Bacillus
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Gingivitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Kidney Infection
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Sinusitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Viral Infection
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Viral Myositis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Seizure
|
14.5%
17/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Somnolence
|
8.5%
10/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Dizziness
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Headache
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Sedation
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Status Epilepticus
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Tremor
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Drooling
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Hemiplegia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Parkinsonism
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
7/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
4/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Dental Caries
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Nausea
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Pyrexia
|
7.7%
9/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Fatigue
|
4.3%
5/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Decreased Activity
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Pain
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
General disorders
Swelling
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
6/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Sleep Disorder
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Abnormal Behaviour
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Agitation
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Anxiety
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Confusional State
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Irritability
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
4/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.4%
4/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Abnormal Weight Gain
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Shagreen Skin
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
2.6%
3/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Investigations
Weight Increased
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Investigations
Blood Homocysteine Increased
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Investigations
Electrocardiogram Abnormal
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Investigations
Specific Gravity Urine Increased
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Cardiac disorders
Tachycardia
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Renal and urinary disorders
Renal Pain
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Vascular disorders
Haematoma
|
1.7%
2/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Vascular disorders
Hypertension
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Eye disorders
Chalazion
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Eye disorders
Scleral Discolouration
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Immune system disorders
Allergy To Arthropod Bite
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Immune system disorders
Seasonal Allergy
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiofibroma
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous Histiocytoma
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Endocrine disorders
Central Hypothyroidism
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Hepatobiliary disorders
Hepatic Lesion
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Mastoiditis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
|
Infections and infestations
Bronchitis
|
0.85%
1/117 • Up to 150 Weeks
Serious TEAEs and TEAEs were collected in the Safety Analysis Set which comprised of all participants who received at least 1 dose of the investigational drug.
|
Additional Information
Marinus Clinical Trials Submission Manager
Marinus Pharmaceuticals, Inc.
Phone: 484-801-4670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60