Trial Outcomes & Findings for Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL) (NCT NCT03711578)
NCT ID: NCT03711578
Last Updated: 2021-08-12
Results Overview
ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
7 months
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
Tenalisib
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Baseline characteristics by cohort
| Measure |
Tenalisib
n=20 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Age, Continuous
|
66.575 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment
ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)
Outcome measures
| Measure |
Tenalisib
n=19 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Objective Response Rate (ORR)
|
5.3 Percent of participants
Interval 0.13 to 26.03
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment
CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.
Outcome measures
| Measure |
Tenalisib
n=19 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Complete Response Rate
|
0.00 Percent of participants
Interval 0.0 to 17.65
|
PRIMARY outcome
Timeframe: From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 monthsPopulation: Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment
PFS is defined as the time of the first dose of Tenalisib to disease progression or death.
Outcome measures
| Measure |
Tenalisib
n=19 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Progression Free Survival (PFS)
|
113 days
Interval 57.0 to 275.0
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment
DoR is measured from the initial response to disease progression or death
Outcome measures
| Measure |
Tenalisib
n=19 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Duration of Response (DoR)
|
0 days
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Patients who received at least 1 dose of study medication
Safety and tolerability of Tenalisib
Outcome measures
| Measure |
Tenalisib
n=20 Participants
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0
|
18 participants
|
Adverse Events
Tenalisib
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenalisib
n=20 participants at risk
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
Other adverse events
| Measure |
Tenalisib
n=20 participants at risk
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
Tenalisib,: BID, Orally
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
4/20 • Number of events 4 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
General disorders
Fatigue
|
25.0%
5/20 • Number of events 5 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Investigations
Neutrophil Count Decreased
|
10.0%
2/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
3/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
4/20 • Number of events 5 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Gastrointestinal disorders
Eructation
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Immune system disorders
Allergy to arthropod bite
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Escherichia urinary tract infection
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Fungal infection
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Serratia infection
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 3 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 2 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Nervous system disorders
Neurological symptoms
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Renal and urinary disorders
Nocturia
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
5.0%
1/20 • Number of events 1 • 8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place