Trial Outcomes & Findings for Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults (NCT NCT03135028)
NCT ID: NCT03135028
Last Updated: 2020-03-06
Results Overview
Occurrence of any of the following toxicities, attributable to ENTO, during Cycle 1 was considered DLT: * Grade 4 non-hematologic toxicity except alopecia, nausea, and vomiting controllable with anti-emetic therapy, line associated venous thrombosis, infection-related toxicities such as fever/sepsis, and fatigue. * In participants without bone marrow evidence of hematologic malignancy, hematologic toxicity defined as failure to recover absolute neutrophil count (ANC \> 500/μL) or platelet count (\>25000/μL) within 28 days * Grade 4, clinically significant, electrolyte abnormalities that were not correctable within 24 hours * Liver function test abnormalities that did not resolve to Grade 2 within 10 days * Infection that resulted from unexpectedly complicated prolonged myelosuppression * Toxicities that required temporary interruption of treatment and did not resolve to Grade 2 within 10 days or ENTO was suspended or dose reduced for a period of more than 10 days.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Cycle 1 (28-day cycle)
Results posted on
2020-03-06
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 19 May 2017. The last study visit occurred on 26 February 2019.
13 participants were screened.
Participant milestones
| Measure |
ENTO 400 mg
Participants received entospletinib (ENTO) 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
ENTO 400 mg
Participants received entospletinib (ENTO) 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Study Terminated by Sponsor
|
2
|
|
Overall Study
Withdrew Consent
|
1
|
Baseline Characteristics
Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults
Baseline characteristics by cohort
| Measure |
ENTO 400 mg
n=9 Participants
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28-day cycle)Population: The DLT Analysis Set included all participants in the Full Analysis Set (all participants who received at least 1 dose of study drug \[ENTO\]) who received at least 21 days of ENTO or experienced a DLT during DLT assessment window.
Occurrence of any of the following toxicities, attributable to ENTO, during Cycle 1 was considered DLT: * Grade 4 non-hematologic toxicity except alopecia, nausea, and vomiting controllable with anti-emetic therapy, line associated venous thrombosis, infection-related toxicities such as fever/sepsis, and fatigue. * In participants without bone marrow evidence of hematologic malignancy, hematologic toxicity defined as failure to recover absolute neutrophil count (ANC \> 500/μL) or platelet count (\>25000/μL) within 28 days * Grade 4, clinically significant, electrolyte abnormalities that were not correctable within 24 hours * Liver function test abnormalities that did not resolve to Grade 2 within 10 days * Infection that resulted from unexpectedly complicated prolonged myelosuppression * Toxicities that required temporary interruption of treatment and did not resolve to Grade 2 within 10 days or ENTO was suspended or dose reduced for a period of more than 10 days.
Outcome measures
| Measure |
ENTO 400 mg
n=6 Participants
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 Up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)Population: Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
Outcome measures
| Measure |
ENTO 400 mg
n=9 Participants
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Percentage of Participants With AEs and Laboratory Abnormalities Not Defined as DLT
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 (28-days cycle) Day 8 at 0 (predose), 1, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: Pharmacokinetic (PK) Analysis Set included all participants in the Full Analysis Set who had necessary baseline and at least 1 non-missing post-treatment assessments. Participants with available data were analyzed. PK parameters were not derived from the collected data due to the early study termination.
Plasma concentration of drug (ENTO) over different time points is reported.
Outcome measures
| Measure |
ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 6 hours postdose
|
1139.3 ng/mL
Standard Deviation 709.22
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, predose
|
921.9 ng/mL
Standard Deviation 610.47
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 1 hour postdose
|
1395.7 ng/mL
Standard Deviation 1081.40
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 2 hours postdose
|
1892.7 ng/mL
Standard Deviation 1285.08
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 3 hours postdose
|
1529.1 ng/mL
Standard Deviation 994.69
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 4 hours postdose
|
1350.0 ng/mL
Standard Deviation 862.21
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 8 hours postdose
|
1075.9 ng/mL
Standard Deviation 659.08
|
|
Plasma Concentration of ENTO
Cycle 1 Day 8, 12 hours postdose
|
855.1 ng/mL
Standard Deviation 568.18
|
Adverse Events
ENTO 400 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ENTO 400 mg
n=9 participants at risk
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Eye disorders
Choroidal haemorrhage
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Clostridium difficile colitis
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Enterococcal infection
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Injury, poisoning and procedural complications
Hyphaema
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
Other adverse events
| Measure |
ENTO 400 mg
n=9 participants at risk
Participants received ENTO 400 mg (2 × 200 mg tablets) orally twice daily in a fasted state on Days 1 through 28 of every 28-day cycle, and continued on study treatment as long as the participant experienced benefit and did not meet the criteria for study treatment discontinuation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Eye disorders
Conjunctival haemorrhage
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Eye disorders
Glaucoma
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Gingival bleeding
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Melaena
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Stomatitis
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
General disorders
Oedema
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Oral herpes
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
4/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Amylase increased
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
3/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Blood bilirubin increased
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Lipase increased
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Psychiatric disorders
Delirium
|
33.3%
3/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Renal and urinary disorders
Renal impairment
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Day 1 up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)
Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER