Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH (NCT NCT03985423)
NCT ID: NCT03985423
Last Updated: 2023-10-06
Results Overview
Achievement of either a Complete or Partial Response Complete Response is adjudicated if the following are observed: * No fever = body temperature \<37.5°C * Normal spleen size * No cytopenia = Absolute Neutrophil Counts \>=1.0x10\^9/L and platelet count \>=100x10\^9/L \[absence of G-CSF and transfusion support must be documented for at least 4 days to report no cytopenia\] * No hyperferritinemia = serum level is \<2000 µg/L * No evidence of coagulopathy, i.e., normal D-Dimer and/or normal (\>150 mg/dL) fibrinogen levels * No neurological and CSF abnormalities attributed to HLH * No sustained worsening of sCD25 (as indicated by at least two consecutive measurements that are \>2-fold higher than baseline) Partial Response is adjudicated if there is an improvement (\>50% change from baseline or normalization) of at least 3 HLH clinical and laboratory criteria (including Central Nervous System abnormalities).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Week 4
Results posted on
2023-10-06
Participant Flow
This Phase 2/3, open-label, single arm study was conducted in adult patients with hemophagocytic lymphohistiocytosis (HLH) at a single center in the United States of America.
The study consisted of a screening (up to 2 weeks), treatment period (until clinically satisfactory response was achieved), and follow-up period (1 year). A total of 7 patients were enrolled in the study and treated.
Participant milestones
| Measure |
Emapalumab
Patients were administered emapalumab 6 milligram per kilogram (mg/kg) intravenous (IV) infusion for 1 to 2 hours, and continued at 3 mg/kg every 3 days for the first 2 weeks, and then twice-a-week until clinically satisfactory response was achieved.
If the treating physician deemed appropriate, the dose of emapalumab could be increased (up to 10 mg/kg), guided by clinical and laboratory response.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Emapalumab
Patients were administered emapalumab 6 milligram per kilogram (mg/kg) intravenous (IV) infusion for 1 to 2 hours, and continued at 3 mg/kg every 3 days for the first 2 weeks, and then twice-a-week until clinically satisfactory response was achieved.
If the treating physician deemed appropriate, the dose of emapalumab could be increased (up to 10 mg/kg), guided by clinical and laboratory response.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of insurance and citizenship
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
Baseline characteristics by cohort
| Measure |
Emapalumab
n=7 Participants
Patients were administered emapalumab 6 mg/kg IV infusion for 1 to 2 hours, and continued at 3 mg/kg every 3 days for the first 2 weeks, and then twice-a-week until clinically satisfactory response was achieved.
If the treating physician deemed appropriate, the dose of emapalumab could be increased (up to 10 mg/kg), guided by clinical and laboratory response.
|
|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
|
Age, Customized
>= 18 and 64 years
|
6 Participants
n=99 Participants
|
|
Age, Customized
>= 65 and 84 years
|
1 Participants
n=99 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
|
Weight
|
80.84 kg
STANDARD_DEVIATION 11.855 • n=99 Participants
|
|
Height
|
168.59 centimeter
STANDARD_DEVIATION 12.234 • n=99 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Since the study was prematurely terminated, no data was collected for the primary efficacy endpoint.
Achievement of either a Complete or Partial Response Complete Response is adjudicated if the following are observed: * No fever = body temperature \<37.5°C * Normal spleen size * No cytopenia = Absolute Neutrophil Counts \>=1.0x10\^9/L and platelet count \>=100x10\^9/L \[absence of G-CSF and transfusion support must be documented for at least 4 days to report no cytopenia\] * No hyperferritinemia = serum level is \<2000 µg/L * No evidence of coagulopathy, i.e., normal D-Dimer and/or normal (\>150 mg/dL) fibrinogen levels * No neurological and CSF abnormalities attributed to HLH * No sustained worsening of sCD25 (as indicated by at least two consecutive measurements that are \>2-fold higher than baseline) Partial Response is adjudicated if there is an improvement (\>50% change from baseline or normalization) of at least 3 HLH clinical and laboratory criteria (including Central Nervous System abnormalities).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4; End of Treatment Visit (on average of 12 weeks)Population: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Treatment Visit (on average of 12 weeks)Population: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Treatment Visit (on average of 12 weeks)Population: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4; End of Treatment visit (on average of 12 weeks)Population: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary efficacy endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary safety endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary Pharmacokinetic endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary Pharmacodynamic endpoints.
Levels of interferon-gamma, C-X-C chemokine ligand 9, soluble CD25, interleukin-6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after last emapalumab administrationPopulation: Since the study was prematurely terminated, no data was collected for the secondary Pharmacodynamic endpoints.
As no data are reported for this outcome measure, additional method is not applicable in the outcome measure description.
Outcome measures
Outcome data not reported
Adverse Events
Emapalumab
Serious events: 5 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Emapalumab
n=7 participants at risk
Patients were administered emapalumab 6 mg/kg IV infusion for 1 to 2 hours, and continued at 3 mg/kg every 3 days for the first 2 weeks, and then twice-a-week until clinically satisfactory response was achieved.
If the treating physician deemed appropriate, the dose of emapalumab could be increased (up to 10 mg/kg), guided by clinical and laboratory response.
|
|---|---|
|
Blood and lymphatic system disorders
Acute myeloid leukaemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Blood and lymphatic system disorders
Lymphoma
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Bacteramia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Fungaemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Fungal skin infection
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Human herpesvirus 6 encephalitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Perineal abscess
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
Other adverse events
| Measure |
Emapalumab
n=7 participants at risk
Patients were administered emapalumab 6 mg/kg IV infusion for 1 to 2 hours, and continued at 3 mg/kg every 3 days for the first 2 weeks, and then twice-a-week until clinically satisfactory response was achieved.
If the treating physician deemed appropriate, the dose of emapalumab could be increased (up to 10 mg/kg), guided by clinical and laboratory response.
|
|---|---|
|
Blood and lymphatic system disorders
Hypercoagulation
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Cardiac disorders
Sinus tachycardia
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Haematochezia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Lip disorder
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Mouth ulceration
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Stomatitis
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
General disorders
Peripheral swelling
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
General disorders
Pyrexia
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Bacteraemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Escherichia bacteramia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Fungaemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Infections and infestations
Meningitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Investigations
Blood osmolarity increased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Investigations
Transaminases increased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Investigations
Troponin T increased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Confusional state
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Paresthesia
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Nervous system disorders
Seizure
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Psychiatric disorders
Ajustment disorder with depressed mood
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Psychiatric disorders
Confusional state
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Psychiatric disorders
Irritability
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Psychiatric disorders
Mental status changes
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Surgical and medical procedures
Dental disorder prophylaxis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
|
Vascular disorders
Penile haemorrhage
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) reported from the first emapalumab administration up to and including Day+60 study visit were recorded, approximately 13 months.
The All Treated analysis set included all patients who received at least 1 dose or 1 incomplete dose of emapalumab. Only TEAEs are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60