A Study of Duvelisib in Participants With Relapsed or Ref... | NCT03372057

ID	Type	Description	Link
2019-001123-13	EudraCT Number

Label	Type	Description	Intervention Names
Dose Optimization Phase: Cohort 1	Experimental	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.	Drug: Duvelisib
Dose Optimization Phase: Cohort 2	Experimental	Duvelisib 75 mg PO BID, administered in 28-day cycles.	Drug: Duvelisib
Expansion Phase	Experimental	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).	Drug: Duvelisib

Name	Type	Description	Arm Group Labels	Other Names
Duvelisib	Drug	Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.	Dose Optimization Phase: Cohort 1

Measure	Description	Time Frame
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria	ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.	56 days (2 cycles; 28-day cycles)
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria	ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.	56 days (2 cycles; 28-day cycles)

Measure	Description	Time Frame
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria	DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010	United States
University of California - Irvine

PubMed Identifier	Type	Citation	Retractions
42018969	Derived	Mehta-Shah N, Zinzani PL, Jacobsen ED, Zain J, Mead M, Casulo C, Gritti G, Pinter-Brown L, Izutsu K, Sidransky D, Bentur OS, Pro B, Fox CP, Brammer JE, Horwitz SM. Duvelisib Induces Deep Responses in Peripheral T-Cell Lymphoma: Final Results of the Phase II PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2026 May 20:JCO2503120. doi: 10.1200/JCO-25-03120. Online ahead of print.

ID	Title	Description
FG000	Dose Optimization Phase: Cohort 1	Duvelisib was administered orally (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 24, 2021	Nov 5, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria

ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.

Posted

Number

95% Confidence Interval

percentage of participants

56 days (2 cycles; 28-day cycles)

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.

Units	Counts
Participants	OG00013 OG00113

Title

Denominators

Categories

Title	Measurements
	OG00053.8(26.7 to 80.9) OG00153.8(26.7 to 80.9)

Primary

ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria

ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.

Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.

Posted

Number

95% Confidence Interval

percentage of participants

56 days (2 cycles; 28-day cycles)

ID	Title	Description
OG000	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria

DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.

Posted

Median

95% Confidence Interval

month

Up to 70 months

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.

Secondary

Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria

PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.

Posted

Median

95% Confidence Interval

month

Up to 70 months

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.

Units	Counts

Secondary

Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria

DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks.

Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 8 weeks

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.

Units	Counts
Participants

Secondary

DOR as Assessed by the IRC Using the Lugano Criteria

DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.

Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.

Posted

Median

95% Confidence Interval

month

Up to 70 months

ID	Title	Description
OG000	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Units	Counts
Participants	OG000

Secondary

PFS as Assessed by the IRC Using the Lugano Criteria

PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.

Posted

Median

95% Confidence Interval

months

Up to 70 months

ID	Title	Description
OG000	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Units	Counts
Participants	OG000

Secondary

DCR as Assessed by the IRC Using the Lugano Criteria

DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 8 weeks

ID	Title	Description
OG000	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.

Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

month

Up to 70 months

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.
OG002	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Secondary

Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)

Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).

Safety Analysis Set: all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those who were evaluable for this outcome measure, and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.

Posted

Mean

Standard Deviation

ng/mL

Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)

ID	Title	Description
OG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
OG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.
OG002	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0029 affected123 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0022 affected123 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Disease progression	General disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0010 affected13 at risk EG00210 affected123 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0013 affected13 at risk EG0026 affected123 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
General physical health deterioration	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0010 affected13 at risk EG0024 affected123 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0011 affected13 at risk EG0023 affected123 at risk
Bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Coronavirus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Cryptococcosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Escherichia sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Febrile infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Herpes simplex viraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Infective spondylitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Systemic candida	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0023 affected123 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0023 affected123 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Epstein-Barr virus associated lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Presyncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Vascular dementia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Completed suicide	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Allogenic stem cell transplantation	Surgical and medical procedures	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Embolism	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0007 affected20 at risk EG0015 affected13 at risk EG00234 affected123 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0027 affected123 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0027 affected123 at risk
Tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0024 affected123 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Cataract	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Dry eye	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Eye irritation	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Periorbital oedema	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Vitreous floaters	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0014 affected13 at risk EG00213 affected123 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected20 at risk EG0012 affected13 at risk EG00222 affected123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0009 affected20 at risk EG0019 affected13 at risk EG00241 affected123 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0028 affected123 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0029 affected123 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0012 affected13 at risk EG0021 affected123 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0009 affected20 at risk EG0016 affected13 at risk EG00231 affected123 at risk
Oral pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0012 affected13 at risk EG0023 affected123 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0013 affected13 at risk EG00215 affected123 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected20 at risk EG0012 affected13 at risk EG00216 affected123 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0028 affected123 at risk
Face oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0007 affected20 at risk EG0016 affected13 at risk EG00238 affected123 at risk
Generalised oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0023 affected123 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected20 at risk EG0013 affected13 at risk EG00219 affected123 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected20 at risk EG0016 affected13 at risk EG00228 affected123 at risk
Swelling face	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Adenovirus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0027 affected123 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Eye infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0012 affected13 at risk EG0020 affected123 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Mucosal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Oral candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0022 affected123 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0017 affected13 at risk EG00247 affected123 at risk
Amylase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0029 affected123 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0015 affected13 at risk EG00245 affected123 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0011 affected13 at risk EG00212 affected123 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG00210 affected123 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0010 affected13 at risk EG00216 affected123 at risk
Blood culture positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Blood immunoglobulin G decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Blood lactate dehydrogenase	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG00220 affected123 at risk
Immunoglobulins decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Lipase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0010 affected13 at risk EG00213 affected123 at risk
Lymphocyte count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0012 affected13 at risk EG00217 affected123 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0008 affected20 at risk EG0013 affected13 at risk EG00241 affected123 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG00011 affected20 at risk EG0016 affected13 at risk EG00234 affected123 at risk
Urine output decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0020 affected123 at risk
Weight decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0013 affected13 at risk EG0028 affected123 at risk
Weight increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0024 affected123 at risk
White blood cell count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0007 affected20 at risk EG0013 affected13 at risk EG00225 affected123 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG00211 affected123 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0014 affected13 at risk EG0024 affected123 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0022 affected123 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG00212 affected123 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0027 affected123 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0013 affected13 at risk EG00210 affected123 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected20 at risk EG0014 affected13 at risk EG00213 affected123 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0026 affected123 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0012 affected13 at risk EG00215 affected123 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0012 affected13 at risk EG0021 affected123 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG00217 affected123 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0011 affected13 at risk EG0029 affected123 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0023 affected123 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0027 affected123 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0024 affected123 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0011 affected13 at risk EG0025 affected123 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0012 affected13 at risk EG0029 affected123 at risk
Dysgeusia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG00210 affected123 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0013 affected13 at risk EG0028 affected123 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG0029 affected123 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0010 affected13 at risk EG0028 affected123 at risk
Presyncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Sciatica	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0025 affected123 at risk
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0010 affected13 at risk EG0021 affected123 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected20 at risk EG0010 affected13 at risk EG00210 affected123 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Urinary retention	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected20 at risk EG0014 affected13 at risk EG00215 affected123 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0011 affected13 at risk EG00217 affected123 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0026 affected123 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0010 affected13 at risk EG00211 affected123 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0025 affected123 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0023 affected123 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected20 at risk EG0013 affected13 at risk EG00213 affected123 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0012 affected13 at risk EG0026 affected123 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0024 affected123 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0012 affected13 at risk EG0024 affected123 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0022 affected123 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0013 affected13 at risk EG00220 affected123 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0013 affected13 at risk EG00214 affected123 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0014 affected13 at risk EG0023 affected123 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0021 affected123 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0007 affected20 at risk EG0012 affected13 at risk EG00221 affected123 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0012 affected13 at risk EG0022 affected123 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected20 at risk EG0011 affected13 at risk EG00216 affected123 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected20 at risk EG0012 affected13 at risk EG00212 affected123 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected20 at risk EG0011 affected13 at risk EG0020 affected123 at risk

ID	Term
D016411	Lymphoma, T-Cell, Peripheral
D008223	Lymphoma
D016399	Lymphoma, T-Cell
D012008	Recurrence

ID	Term
D008228	Lymphoma, Non-Hodgkin
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
BG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.
BG002	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose Optimization Phase: Cohort 1	Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.	16	20	14	20	19	20
EG001	Dose Optimization Phase: Cohort 2	Duvelisib 75 mg PO BID, administered in 28-day cycles.	11	13	9	13	13	13
EG002	Expansion Phase	Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).	78	123	60	123	121	123