Familial Cold Autoinflammatory Syndrome
Conditions
Keywords
Familial Cold Auto-inflammatory Syndrome, FCAS, DFV890, NLRP3 inhibitor, inflammasome inhibition, Cryopyrin-associated periodic syndromes, CAPS
Brief summary
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
Detailed description
This was an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS who showed evidence of inflammatory activity after the cold challenge performed during screening. The study included a screening period, a treatment period and a follow-up period.
Interventions
DRUGDFV890
100 mg of DFV890 film coated tablets twice daily (b.i.d.). for 3 days starting in the morning of Day 1 and 100 mg of DFV890 in the morning on the fourth day.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any study-specific assessment is performed * Body mass index within the range of 18-35 kg/m2 * Patients with a genetic diagnosis of FCAS * Patients with a clinical history and investigations consistent with FCAS
Exclusion criteria
* Anti-rejection and/or immunomodulatory drugs must be discontinued (please, see protocol for further details) * Clinically significant, suspected active or chronic bacterial (including Mycobacterium tuberculosis), viral or fungal infection within 30 days prior to Day 1. * Patients with innate (e.g. TLR immunodeficiencies, defects in IFN-γ signaling) or acquired immune deficiencies (e.g. AIDS). * Presence of human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc), or hepatitis C antibodies at screening. * Live vaccines within 4 weeks of Day 1 * Pregnant or nursing (lactating) women. * Women of child-bearing potential unless they are using highly effective methods of contraception. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period | Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes. | A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening period, which is a favorable outcome. The log-transformed fold change from pre-challenge to the highest post challenge WCC was analyzed using a log-linear mixed effect model. The analysis was carried out considering the data from -2 to 8 hrs post challenge. The unforeseen screen failure rate and recruitment challenges resulted in early closure of the study. Only 4 out of planned 6 participants were enrolled in the study; thus, the results should be interpreted cautiously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days | Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation. |
| Physician Global Assessment of Autoinflammatory Disease Activity | Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes. | The Physician global assessment of autoinflammatory disease activity is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe |
| Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes. | The Physician's severity assessment of autoinflammatory disease signs and symptoms is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe The following items were assessed: * Assessment of skin disease (urticarial skin rash) * Assessment of arthralgia * Assessment of myalgia * Assessment of headache/migraine * Assessment of conjunctivitis * Assessment of fatigue/malaise |
| Patient's Global Assessment of Disease Activity | Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes. | Patient's global assessment of disease activity is a questionnaire completed by the patient. It uses a 5-point scale. The patient selected a rating based on the patient's current disease activity at the time of the assessment. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe |
Countries
France, Germany, United States
Participant flow
Recruitment details
Participants took part in 3 investigative sites in 3 countries.
Pre-assignment details
During the screening period the participant's eligibility was assessed at a screening visit and a screening cold challenge was performed.
Participants by arm
| Arm | Count |
|---|---|
| DFV890 100mg - Treatment DFV890 100mg oral dose, twice daily for 3 days and one last dose in the morning of Day 4 of the treatment period | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | DFV890 100mg - Treatment |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 15.48 |
| Race/Ethnicity, Customized other | 1 Participants |
| Race/Ethnicity, Customized white | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period
A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening period, which is a favorable outcome. The log-transformed fold change from pre-challenge to the highest post challenge WCC was analyzed using a log-linear mixed effect model. The analysis was carried out considering the data from -2 to 8 hrs post challenge. The unforeseen screen failure rate and recruitment challenges resulted in early closure of the study. Only 4 out of planned 6 participants were enrolled in the study; thus, the results should be interpreted cautiously.
Time frame: Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes.
Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| DFV890 100mg | Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period | 0.82 ratio of fold change |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 34 days
Population: The safety analysis set included all participants that received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DFV890 100mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least one AE | 4 Participants |
| DFV890 100mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least one SAE | 0 Participants |
| DFV890 100mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE leading to discontinuation | 0 Participants |
| DFV890 100mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE leading to discontinuation | 0 Participants |
Secondary
Patient's Global Assessment of Disease Activity
Patient's global assessment of disease activity is a questionnaire completed by the patient. It uses a 5-point scale. The patient selected a rating based on the patient's current disease activity at the time of the assessment. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe
Time frame: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 5 hours post | Absent | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 5 hours post | Minimal | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 1 hour pre | Minimal | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 5 hours post | Mild | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 2 hours post | Absent | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 3 hours post | Absent | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 9 hours post | Absent | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 9 hours post | Minimal | 1 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 3 hours post | Minimal | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 9 hours post | Mild | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 2 hours post | Minimal | 4 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 9 hours post | Moderate | 1 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 3 hours post | Mild | 2 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 1 hour pre | Mild | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 24 hours post | Absent | 1 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 24 hours post | Minimal | 3 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 2 hours post | Mild | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 24 hours post | Mild | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Patient's Global Assessment of Disease Activity | 1 hour pre | Absent | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 1 hour pre | Absent | 3 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 1 hour pre | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 2 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 2 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 2 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 3 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 3 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 5 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 5 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 9 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 9 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 24 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 24 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Patient's Global Assessment of Disease Activity | 24 hours post | Moderate | 0 Participants |
Secondary
Physician Global Assessment of Autoinflammatory Disease Activity
The Physician global assessment of autoinflammatory disease activity is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe
Time frame: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Minimal | 3 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Mild | 3 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Minimal | 2 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Moderate | 3 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Mild | 3 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Mild | 1 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Minimal | 3 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Mild | 2 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Absent | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Absent | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Mild | 1 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician Global Assessment of Autoinflammatory Disease Activity | 24 hours post | Moderate | 0 Participants |
Secondary
Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms
The Physician's severity assessment of autoinflammatory disease signs and symptoms is a questionnaire completed by the Investigator. It uses a 5-point scale. Lower scores represent better outcomes. 0 = Absent 1. = Minimal 2. = Mild 3. = Moderate 4. = Severe The following items were assessed: * Assessment of skin disease (urticarial skin rash) * Assessment of arthralgia * Assessment of myalgia * Assessment of headache/migraine * Assessment of conjunctivitis * Assessment of fatigue/malaise
Time frame: Screening and Treatment (Day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. Scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). The start of the cold challenge is at 1 hour post and the duration is 45 minutes.
Population: The Pharmacodynamic (PD) analysis set included all participants with no protocol deviations with relevant impact on PD data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Absent | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Moderate | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Absent | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Moderate | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Absent | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Minimal | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Absent | 4 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Mild | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Minimal | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Absent | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Mild | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Absent | 2 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Mild | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Minimal | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Moderate | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Mild | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Minimal | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Moderate | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Mild | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Absent | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Minimal | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Minimal | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Mild | 1 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Moderate | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Absent | 3 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Severe | 0 Participants |
| DFV890 100mg | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Arthralgia 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Conjunctivitis 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Mild | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Moderate | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Moderate | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Moderate | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Moderate | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Fatigue/Malaise 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Headache/Migraine 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Minimal | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Absent | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Absent | 4 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Minimal | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Myalgia 24 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Absent | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Minimal | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 1 hour pre | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Absent | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Minimal | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 2 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 3 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 5 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Absent | 1 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Minimal | 3 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Moderate | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 9 hours post | Severe | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Absent | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Minimal | 2 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Mild | 0 Participants |
| DFV890 100mg - Treatment | Physician's Severity Assessment of Autoinflammatory Disease Signs and Symptoms | Skin disease 24 hours post | Moderate | 0 Participants |