Trial Outcomes & Findings for Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (NCT NCT01732926)

Last Updated: 2018-11-16

Results Overview

PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

475 participants

Results posted on

2018-11-16

Participant Flow

Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.

581 participants were screened.

Participant milestones

Participant milestones
Measure	Idelalisib + Bendamustine + Rituximab Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) \+ rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	Placebo + Bendamustine + Rituximab Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
Overall Study STARTED	320	155
Overall Study COMPLETED	53	45
Overall Study NOT COMPLETED	267	110

Reasons for withdrawal

Reasons for withdrawal
Measure	Idelalisib + Bendamustine + Rituximab Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) \+ rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	Placebo + Bendamustine + Rituximab Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
Overall Study Study Terminated by Sponsor	168	80
Overall Study Withdrawal by Subject	46	8
Overall Study Physician Decision	24	11
Overall Study Other Reason	21	4
Overall Study Initiation of Other Anti-Cancer Therapy	7	6
Overall Study Blind Broken by Subject or Study Site	1	1

Baseline Characteristics

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Idelalisib + Bendamustine + Rituximab n=320 Participants Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	Placebo + Bendamustine + Rituximab n=155 Participants Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	Total n=475 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 10.5 • n=5 Participants	62 years STANDARD_DEVIATION 11.1 • n=7 Participants	62 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	58 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	188 Participants n=5 Participants	97 Participants n=7 Participants	285 Participants n=5 Participants
Race/Ethnicity, Customized Asian	26 Participants n=5 Participants	8 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	247 Participants n=5 Participants	122 Participants n=7 Participants	369 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Not Permitted	42 Participants n=5 Participants	18 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	262 Participants n=5 Participants	129 Participants n=7 Participants	391 Participants n=5 Participants
Region of Enrollment Russian Federation	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	12 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United Kingdom	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Spain	21 Participants n=5 Participants	11 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Canada	47 Participants n=5 Participants	19 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment Czech Republic	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Sweden	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Taiwan	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Poland	25 Participants n=5 Participants	11 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Korea, Republic of	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Italy	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Israel	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment France	36 Participants n=5 Participants	18 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Australia	44 Participants n=5 Participants	23 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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.

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 is defined as the proportion of participants who achieve a complete response. CR 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.

Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR 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.

Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node 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 mature for all participants, and therefore the prespecified analyses were not conducted.

Overall survival is defined as the interval from randomization to death from any cause.

Outcome measures

Outcome data not reported

Adverse Events

Idelalisib + Bendamustine + Rituximab

Serious events: 229 serious events

Other events: 315 other events

Deaths: 0 deaths

Placebo + Bendamustine + Rituximab

Serious events: 58 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Disclosures

Gilead Sciences

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

Measure	Idelalisib + Bendamustine + Rituximab n=317 participants at risk Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)	Placebo + Bendamustine + Rituximab n=155 participants at risk Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
Vascular disorders Hypotension	5.0% 16/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.2% 5/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Blood and lymphatic system disorders Anaemia	16.1% 51/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	11.6% 18/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Blood and lymphatic system disorders Leukopenia	5.7% 18/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	4.5% 7/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Blood and lymphatic system disorders Neutropenia	38.5% 122/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	34.8% 54/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Blood and lymphatic system disorders Thrombocytopenia	11.7% 37/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	11.6% 18/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Abdominal pain	12.3% 39/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.1% 11/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Abdominal pain upper	6.6% 21/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	6.5% 10/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Constipation	23.3% 74/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	20.0% 31/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Diarrhoea	49.8% 158/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	21.3% 33/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Dry mouth	6.3% 20/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.9% 3/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Dyspepsia	8.8% 28/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.8% 9/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Gastrooesophageal reflux disease	5.4% 17/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.9% 6/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Mouth ulceration	6.3% 20/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	2.6% 4/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Nausea	50.2% 159/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	41.9% 65/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Stomatitis	8.2% 26/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.2% 5/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Gastrointestinal disorders Vomiting	31.5% 100/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	16.1% 25/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Asthenia	13.6% 43/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	15.5% 24/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Chills	12.3% 39/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	6.5% 10/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Fatigue	32.5% 103/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	32.9% 51/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Mucosal inflammation	9.1% 29/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.3% 2/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Oedema peripheral	12.0% 38/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	4.5% 7/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
General disorders Pyrexia	42.6% 135/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	14.2% 22/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Bronchitis	6.9% 22/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	8.4% 13/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Herpes zoster	6.0% 19/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	4.5% 7/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Lower respiratory tract infection	4.4% 14/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.8% 9/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Nasopharyngitis	5.4% 17/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	9.0% 14/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Oral candidiasis	5.4% 17/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.3% 2/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Pneumonia	5.0% 16/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.3% 2/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Sinusitis	5.7% 18/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.1% 11/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Upper respiratory tract infection	18.3% 58/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	16.1% 25/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Infections and infestations Urinary tract infection	8.2% 26/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.2% 8/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Injury, poisoning and procedural complications Infusion related reaction	12.0% 38/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	10.3% 16/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Investigations Alanine aminotransferase increased	20.5% 65/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.9% 3/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Investigations Aspartate aminotransferase increased	16.1% 51/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	2.6% 4/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Investigations Neutrophil count decreased	3.8% 12/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.8% 9/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Investigations Weight decreased	12.9% 41/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.9% 6/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Metabolism and nutrition disorders Decreased appetite	20.5% 65/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	16.1% 25/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Metabolism and nutrition disorders Hypokalaemia	16.4% 52/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.1% 11/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Metabolism and nutrition disorders Hypomagnesaemia	6.0% 19/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	1.3% 2/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 22/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.7% 12/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	7.3% 23/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.7% 12/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.5% 8/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.2% 8/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Myalgia	6.6% 21/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.9% 6/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Pain in extremity	3.5% 11/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.2% 8/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Nervous system disorders Dizziness	7.3% 23/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	6.5% 10/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Nervous system disorders Dysgeusia	5.0% 16/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	6.5% 10/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Nervous system disorders Headache	14.2% 45/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	11.6% 18/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Nervous system disorders Neuropathy peripheral	2.5% 8/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.8% 9/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Nervous system disorders Paraesthesia	2.8% 9/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	5.8% 9/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Psychiatric disorders Insomnia	12.6% 40/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	10.3% 16/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	22.4% 71/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	23.9% 37/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.6% 40/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	7.1% 11/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.9% 25/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	6.5% 10/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Dry skin	6.3% 20/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.2% 5/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Erythema	6.3% 20/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	2.6% 4/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Night sweats	5.0% 16/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.9% 6/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Pruritus	17.0% 54/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	14.2% 22/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Rash	33.1% 105/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	10.3% 16/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 29/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	3.2% 5/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Urticaria	5.0% 16/317 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug	2.6% 4/155 • Up to 34 months plus 30 days Safety Analysis Set: all participants who took at least 1 dose of study drug