Trial Outcomes & Findings for Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion (NCT NCT02044822)
NCT ID: NCT02044822
Last Updated: 2018-11-19
Results Overview
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
102 participants
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 06 August 2014. The last study visit occurred on 17 May 2016.
130 participants were screened.
Participant milestones
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m\^2 intravenously once weekly for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
Idelalisib + Rituximab
Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m\^2 intravenously once weekly for 8 weeks
|
|---|---|
|
Overall Study
Study Terminated by Sponsor
|
77
|
|
Overall Study
Investigator's Discretion
|
10
|
|
Overall Study
Withdrew Consent
|
3
|
|
Overall Study
Initiation of Anti-Neoplastic Therapy
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Baseline characteristics by cohort
| Measure |
Idelalisib + Rituximab
n=102 Participants
Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m\^2 intravenously once weekly for 8 weeks
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
PRIMARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
Overall survival was defined as the interval from the start of study treatment to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib + Rituximab
Serious events: 46 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib + Rituximab
n=102 participants at risk
Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m\^2 intravenously once weekly for 8 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
3/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Cardiac disorders
Cardiac failure
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Enterocolitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Glossitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Stomatitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Malaise
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Pyrexia
|
10.8%
11/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Appendicitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Clostridium difficile colitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Conjunctivitis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Cytomegalovirus infection
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Herpes zoster
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Influenza
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Intestinal sepsis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Oral candidiasis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumonia
|
4.9%
5/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumonia bacterial
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumonia influenzal
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Sepsis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Septic shock
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Body temperature increased
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Liver function test increased
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Transaminases increased
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
3.9%
4/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Nervous system disorders
Facial nerve disorder
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Psychiatric disorders
Confusional state
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
2/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Vascular disorders
Hypotension
|
0.98%
1/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
Other adverse events
| Measure |
Idelalisib + Rituximab
n=102 participants at risk
Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m\^2 intravenously once weekly for 8 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.7%
14/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.5%
24/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.8%
10/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
14.7%
15/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
35.3%
36/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
18.6%
19/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
17/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Asthenia
|
14.7%
15/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Chills
|
12.7%
13/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Fatigue
|
15.7%
16/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Oedema peripheral
|
10.8%
11/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
General disorders
Pyrexia
|
23.5%
24/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Bronchitis
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
10/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Oral candidiasis
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
7/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
38.2%
39/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
21.6%
22/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Transaminases increased
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Investigations
Weight decreased
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.8%
9/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.8%
10/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
10/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Nervous system disorders
Dizziness
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Nervous system disorders
Headache
|
9.8%
10/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Psychiatric disorders
Insomnia
|
6.9%
7/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
19/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
6/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
8/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.5%
28/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.9%
7/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
|
Vascular disorders
Hypertension
|
6.9%
7/102 • Up to 17 months plus 30 days
Intent-to-Treat Analysis Set
|
Additional Information
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