Trial Outcomes & Findings for NUCALA® Special Drug Use Investigation (EGPA, Long-term) (NCT NCT03557060)
NCT ID: NCT03557060
Last Updated: 2026-02-18
Results Overview
ADR is defined as adverse events for which a causal relationship with the drug was not ruled out.
Recruitment status
COMPLETED
Target enrollment
4115 participants
Primary outcome timeframe
Up to 96 Weeks
Results posted on
2026-02-18
Participant Flow
This non-interventional study aims to collect and assess the information on the safety and effectiveness of the long-term use of NUCALA in daily clinical practice in participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA).
A total of 4115 participants were enrolled in the study; however, 836 participants were included in Safety Analysis Population. Safety Analysis Population consisted of the participants with locked case report form \[CRF\]. It includes participants that do not fall under the safety analysis exclusion criteria.
Participant milestones
| Measure |
Participants With EGPA
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Overall Study
STARTED
|
4115
|
|
Overall Study
Safety Analysis Population
|
836
|
|
Overall Study
Locked Case Report Forms
|
847
|
|
Overall Study
COMPLETED
|
687
|
|
Overall Study
NOT COMPLETED
|
3428
|
Reasons for withdrawal
| Measure |
Participants With EGPA
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Overall Study
Physician's decision
|
8
|
|
Overall Study
Withdrawal by Subject
|
35
|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
Financial reasons
|
7
|
|
Overall Study
Lack of Efficacy
|
31
|
|
Overall Study
Symptom improvement
|
12
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Discontinuation due to all Adverse Events
|
31
|
|
Overall Study
Participants only registered and whose CRF was not collected
|
2946
|
|
Overall Study
Participants consent for publication was not obtained
|
322
|
|
Overall Study
Participants excluded from safety analysis
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With EGPA
n=836 Participants
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Age, Continuous
|
59.1 YEARS
STANDARD_DEVIATION 14.9 • n=836 Participants
|
|
Sex: Female, Male
Female
|
488 Participants
n=836 Participants
|
|
Sex: Female, Male
Male
|
348 Participants
n=836 Participants
|
|
Region of Enrollment
Japan
|
836 Participants
n=836 Participants
|
PRIMARY outcome
Timeframe: Up to 96 WeeksPopulation: Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria.
ADR is defined as adverse events for which a causal relationship with the drug was not ruled out.
Outcome measures
| Measure |
Participants With EGPA
n=836 Participants
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs)
|
57 Participants
|
PRIMARY outcome
Timeframe: Up to 96 WeeksPopulation: Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With EGPA
n=804 Participants
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Response Rate Based on Global Assessment of Effectiveness
|
95.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 96 WeeksPopulation: Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above.
Outcome measures
| Measure |
Participants With EGPA
n=42 Participants
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Time to EGPA Relapse
|
133.7 Days
Standard Deviation 160.5
|
Adverse Events
Participants With EGPA
Serious events: 15 serious events
Other events: 46 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Participants With EGPA
n=836 participants at risk
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
General disorders
Death
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Condition aggravated
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Herpes zoster
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Pneumonia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.48%
4/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Investigations
Alanine aminotransferase increased
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
Other adverse events
| Measure |
Participants With EGPA
n=836 participants at risk
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study.
|
|---|---|
|
Nervous system disorders
Hypoaesthesia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Somnolence
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.36%
3/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Hepatobiliary disorders
Liver disorder
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.24%
2/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.24%
2/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.24%
2/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.24%
2/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Headache
|
0.36%
3/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Dizziness
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Nervous system disorders
Dysaesthesia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Malaise
|
0.84%
7/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Condition aggravated
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Asthenia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Injection site pain
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Injection site pruritus
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Injection site reaction
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Pyrexia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
General disorders
Application site purpura
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Herpes zoster
|
0.48%
4/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Bronchitis
|
0.36%
3/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Cystitis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Infections and infestations
Tinea pedis
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Investigations
Immunoglobulins decreased
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Investigations
White blood cell count decreased
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Vascular disorders
Hot flush
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Vascular disorders
Superficial vein prominence
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Eye disorders
Ocular hyperaemia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Eye disorders
Periorbital swelling
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Psychiatric disorders
Insomnia
|
0.12%
1/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.24%
2/836 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER