Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000621-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA.
This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.. In August 2016, sponsorship of the trial was transferred to Biogen.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nusinersen 6 mg | Experimental |
| |
| Nusinersen 12 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nusinersen | Drug | Administered by intrathecal (IT) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit | Section 2 of HINE consists of 8 independent milestone categories. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. Overall, there are a total of 26 milestones that can be achieved across the 8 categories. Improvement was defined as any of the following: 1. An increase from baseline of 2 milestones or more, or the achievement of pincer grasp in the voluntary grasp category 2. An increase from baseline of 2 milestones or more, or achievement of touching toes in the ability to kick category 3. An increase from baseline of 1 milestone or more in any of the remaining 6 categories: head control, rolling, sitting, crawling, standing, or walking. | Day 1352 or Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival at the End of Study | Event-free survival was defined as the percent of participants who were alive and did not require permanent ventilatory support (defined as tracheostomy or the need for ≥16 hours ventilation/day continuously for at least 2 weeks in the absence of an acute reversible illness) Event-free survival was estimated using Kaplan-Meier methodology. | Up to Day 1638 |
Not provided
Key Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Nemours Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34089650 | Derived | Finkel RS, Chiriboga CA, Vajsar J, Day JW, Montes J, De Vivo DC, Bishop KM, Foster R, Liu Y, Ramirez-Schrempp D, Schneider E, Bennett CF, Wong J, Farwell W. Treatment of infantile-onset spinal muscular atrophy with nusinersen: final report of a phase 2, open-label, multicentre, dose-escalation study. Lancet Child Adolesc Health. 2021 Jul;5(7):491-500. doi: 10.1016/S2352-4642(21)00100-0. Epub 2021 Jun 3. | |
| 31420846 |
| Label | URL |
|---|---|
| Cure SMA | View source |
Not provided
Of the 23 participants screened, 2 were screening failures. A total of 21 participants enrolled; 1 was withdrawn from the study due to respiratory failure prior to receiving the first dose of study treatment. Twenty participants received at least 1 dose of study treatment and were included in the efficacy, safety, and PK analyses.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nusinersen 6 mg | Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| FG001 | Nusinersen 12 mg | Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nusinersen 6 mg | Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| BG001 | Nusinersen 12 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit | Section 2 of HINE consists of 8 independent milestone categories. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. Overall, there are a total of 26 milestones that can be achieved across the 8 categories. Improvement was defined as any of the following: 1. An increase from baseline of 2 milestones or more, or the achievement of pincer grasp in the voluntary grasp category 2. An increase from baseline of 2 milestones or more, or achievement of touching toes in the ability to kick category 3. An increase from baseline of 1 milestone or more in any of the remaining 6 categories: head control, rolling, sitting, crawling, standing, or walking. | Safety Population: All participants who were registered and received at least 1 dose of nusinersen. | Posted | Number | Percent of participants | Day 1352 or Early Termination |
|
Up to Day 1359
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nusinersen 6 mg | Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2016 | Aug 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2016 | Aug 16, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590926 | nusinersen |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent of Participants With Improved Motor Function at the Last Visit as Assessed by the CHOP-INTEND Motor Function Scale | The CHOP-INTEND test includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Improvement was defined as an increase in total CHOP INTEND score ≥4 points from baseline as of the last study visit. | Day 1352 or Early Termination |
| Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A positive change from Baseline indicates that the number of motor neurons increased. | Baseline, Day 1072 |
| Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the subject (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor. | Up to Day 1352 |
| Concentration of Nusinersen in Cerebrospinal Fluid (CSF) | The concentration of nusinersen in CSF was measured by using standard laboratory assays. | Day 1135 (Predose) |
| PK Parameters of Nusinersen in Plasma: Maximum Concentration (Cmax) | Cmax is the maximum observed concentration of study drug in plasma. | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
| PK Parameters of Nusinersen in Plasma: Time to Reach Cmax (Tmax) | Tmax is the time at which Cmax occurs. | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
| PK Parameters of Nusinersen in Plasma: Area Under the Plasma Concentrations Time Curve From the Time of the IT Dose to Four Hours After Dosing (AUC0-4) | AUC is area under the plasma concentration-time curve from zero time (Predose) to 4 hours after IT administration of study drug. AUC was determined by using the linear trapezoidal rule. | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
| Orlando |
| Florida |
| 32827 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| The Hospital for Sick Children (SickKids) | Toronto | Ontario | M5G 1X8 | Canada |
| Derived |
| Darras BT, Farrar MA, Mercuri E, Finkel RS, Foster R, Hughes SG, Bhan I, Farwell W, Gheuens S. An Integrated Safety Analysis of Infants and Children with Symptomatic Spinal Muscular Atrophy (SMA) Treated with Nusinersen in Seven Clinical Trials. CNS Drugs. 2019 Sep;33(9):919-932. doi: 10.1007/s40263-019-00656-w. |
| 27939059 | Derived | Finkel RS, Chiriboga CA, Vajsar J, Day JW, Montes J, De Vivo DC, Yamashita M, Rigo F, Hung G, Schneider E, Norris DA, Xia S, Bennett CF, Bishop KM. Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study. Lancet. 2016 Dec 17;388(10063):3017-3026. doi: 10.1016/S0140-6736(16)31408-8. Epub 2016 Dec 7. |
| Muscular Dystrophy Association | View source |
| National Organization for Rare Diseases | View source |
| Clinical Study Report (CSR) Synopsis - a results summary | View source |
| Early study closure |
|
| Adverse Event |
|
Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Hammersmith Infant Neurological Examination (HINE) Head Control Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Sitting Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Voluntary Grasp Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Ability to Kick Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Rolling Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Crawling Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Standing Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| HINE Walking Motor Milestones at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| Distribution of Total Scores of the CHOP-INTEND Scale at Baseline | The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP-INTEND) test includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Count of Participants | Participants |
|
| Mean CHOP INTEND Total Scores at Baseline | The CHOP-INTEND test includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Mean | Standard Deviation | Units on a scale |
|
| Mean Compound Muscle Action Potential (CMAP) Amplitude of the Peroneal Nerve at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Mean | Standard Deviation | millivolts (mV) |
|
| Mean CMAP Amplitude of the Ulnar Nerve at Baseline | Baseline was defined as the last non-missing value prior to the first dose of nusinersen. | Mean | Standard Deviation | mV |
|
| Description |
|---|
| OG000 | Nusinersen 6 mg | Participants received nusinersen 6 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
| OG001 | Nusinersen 12 mg | Participants received nusinersen 12 mg injections as an intrathecal (IT) bolus through a lumbar puncture (LP) on Days 1, 15, and 85. Maintenance doses of 12 mg were given on Days 253, 379, 505, 631, 757, 883, 1009, 1135, and 1261. |
|
|
| Secondary | Event-free Survival at the End of Study | Event-free survival was defined as the percent of participants who were alive and did not require permanent ventilatory support (defined as tracheostomy or the need for ≥16 hours ventilation/day continuously for at least 2 weeks in the absence of an acute reversible illness) Event-free survival was estimated using Kaplan-Meier methodology. | Safety Population: All participants who were registered and received at least 1 dose of nusinersen. | Posted | Number | Percent of participants | Up to Day 1638 |
|
|
|
| Secondary | Percent of Participants With Improved Motor Function at the Last Visit as Assessed by the CHOP-INTEND Motor Function Scale | The CHOP-INTEND test includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Improvement was defined as an increase in total CHOP INTEND score ≥4 points from baseline as of the last study visit. | Safety Population: All participants who were registered and received at least 1 dose of nusinersen. | Posted | Number | Percent of participants | Day 1352 or Early Termination |
|
|
|
| Secondary | Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A positive change from Baseline indicates that the number of motor neurons increased. | Safety Population: All participants who were registered and received at least 1 dose of nusinersen. Here, number of participants analyzed is the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mV | Baseline, Day 1072 |
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the subject (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor. | Safety Population: All participants who were registered and received at least 1 dose of nusinersen. | Posted | Number | participants | Up to Day 1352 |
|
|
|
| Secondary | Concentration of Nusinersen in Cerebrospinal Fluid (CSF) | The concentration of nusinersen in CSF was measured by using standard laboratory assays. | PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample. Here, number of participants analyzed is the participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Day 1135 (Predose) |
|
|
|
| Secondary | PK Parameters of Nusinersen in Plasma: Maximum Concentration (Cmax) | Cmax is the maximum observed concentration of study drug in plasma. | PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
|
|
|
| Secondary | PK Parameters of Nusinersen in Plasma: Time to Reach Cmax (Tmax) | Tmax is the time at which Cmax occurs. | PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample. | Posted | Mean | Standard Deviation | hr | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
|
|
|
| Secondary | PK Parameters of Nusinersen in Plasma: Area Under the Plasma Concentrations Time Curve From the Time of the IT Dose to Four Hours After Dosing (AUC0-4) | AUC is area under the plasma concentration-time curve from zero time (Predose) to 4 hours after IT administration of study drug. AUC was determined by using the linear trapezoidal rule. | PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample. | Posted | Mean | Standard Deviation | ng x hr/mL | Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose ) |
|
|
|
| 1 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| EG001 | Nusinersen 12 mg | Participants aged 21 days to 7 months old with infantile-onset SMA received nusinersen 12 mg injections at regular intervals for up to 45 months. | 4 | 16 | 13 | 16 | 16 | 16 |
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumopericardium | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia adenoviral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Clinodactyly | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| High arched palate | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pectus carinatum | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Plagiocephaly | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Astigmatism | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tongue atrophy | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tooth crowding | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Traumatic tooth displacement | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device leakage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial tracheitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Candida nappy rash | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Erythema infectiosum | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Moraxella infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Mucocutaneous candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia moraxella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Post gastric surgery syndrome | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Human rhinovirus test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Moraxella test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Neutrophil percentage increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Pseudomonas test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Serratia test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Streptococcus test positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Weight gain poor | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deformity thorax | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hand deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Kyphoscoliosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lordosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rib deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Spinal deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drooling | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nystagmus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Speech disorder developmental | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Expressive language disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Laryngeal granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal discharge discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tracheal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Use of accessory respiratory muscles | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Capillary fragility | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Essential hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Subgaleal haematoma | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |