Trial Outcomes & Findings for Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT01780662)

Last Updated: 2021-10-28

Results Overview

MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

During cycle 1 of protocol therapy (21 days)

Results posted on

2021-10-28

Participant Flow

This is a Phase I /II study. Phase I determined the Maximum Tolerated Dose (MTD) between the first 2 treatment arms; 16 patients enrolled and 9 patients completed therapy. The study was closed and reopened to accrual for Phase II which enrolled an additional 30 patients. Overall, 46 patients were enrolled but only 29 patients completed therapy.

Participant milestones

Participant milestones
Measure	Phase I, 1.4mg/kg Patients who were enrolled in Phase I and took dose 1.4mg/kg	Phase I, 1.8mg/kg Patients who were enrolled in Phase I and took dose 1.8mg/kg	Phase II, 1.8mg/kg Patients who were enrolled in Phase lI and took dose 1.8mg/kg
Overall Study STARTED	3	13	30
Overall Study COMPLETED	2	7	20
Overall Study NOT COMPLETED	1	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I, 1.4mg/kg Patients who were enrolled in Phase I and took dose 1.4mg/kg	Phase I, 1.8mg/kg Patients who were enrolled in Phase I and took dose 1.8mg/kg	Phase II, 1.8mg/kg Patients who were enrolled in Phase lI and took dose 1.8mg/kg
Overall Study Adverse Event	1	0	2
Overall Study Physician Decision	0	5	7
Overall Study Protocol Violation	0	1	0
Overall Study Ineligible	0	0	1

Baseline Characteristics

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Dose 1.4 mg/kg n=3 Participants Patients who were enrolled in Phase I and took dose 1.4mg/kg	Phase I Dose 1.8 mg/kg n=13 Participants Patients who were enrolled in Phase I and took dose 1.8mg/kg	Phase 2 Dose 1.8 mg/kg n=30 Participants Patients who were enrolled in Phase lI and took dose 1.8mg/kg	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants	37 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	9 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants	25 Participants n=483 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants	21 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants	11 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants	34 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants	8 Participants n=483 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants	32 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants
Region of Enrollment United States	3 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants	44 Participants n=483 Participants
Region of Enrollment Canada	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: During cycle 1 of protocol therapy (21 days)

Population: The first 9 out of 16 patients enrolled with relapsed/refractory HL in a phase 1 dose finding study of brentuximab vedotin in combination with gemcitabine, were used in determining MTD

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=9 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
Maximum Tolerated Dose (MTD) for Brentuximab Vedotin	1.8 mg/kg	—

PRIMARY outcome

Timeframe: 13 months from first dose

Population: All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=3 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) n=42 Participants Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Abdominal pain	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Adrenal insufficiency	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Alanine aminotransferase increased	1 Participants	13 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Anemia	1 Participants	4 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Anorexia	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Aspartate aminotransferase increased	1 Participants	10 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Dehydration	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Dental caries	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Diarrhea	0 Participants	3 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Febrile neutropenia	0 Participants	2 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 GGT increased	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Hemolytic uremic syndrome	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Hypophosphatemia	0 Participants	2 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Hypotension	0 Participants	4 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Infections and infestations - Other- Specify	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Investigations - Other- Specify	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Lung infection	0 Participants	2 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Lymphocyte count decreased	3 Participants	8 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Myositis	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Nausea	0 Participants	2 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Neutrophil count decreased	3 Participants	28 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Non-cardiac chest pain	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Pain in extremity	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Pericardial effusion	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Platelet count decreased	0 Participants	13 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Pneumonitis	1 Participants	0 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Pruritus	1 Participants	0 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Rash maculo-papular	0 Participants	3 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Skin infection	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Urinary tract infection	0 Participants	1 Participants
Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 White blood cell decreased	3 Participants	15 Participants

PRIMARY outcome

Timeframe: After 4 cycles (21 days per cycle) of protocol therapy

Population: All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=42 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)	28 Participants	—

SECONDARY outcome

Timeframe: Up to 13 months from first dose

Population: All eligible patients in phase 1, dose level 2 (N=13). 3 patients in phase 1 were not given dose level 2.

The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=13 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.	8 Participants	—

SECONDARY outcome

Timeframe: After 4 cycles (21 days per cycle) of protocol therapy

Population: All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine).4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=42 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)	74 percentage of participants Interval 58.0 to 86.0	—

SECONDARY outcome

Timeframe: From 1 to 5 cycles

Population: For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=24 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection	24 Participants	—

SECONDARY outcome

Timeframe: From baseline to time prior to cycle 2

Population: 4 eligible patients did not consent for genetic studies. 3 of the 41 did not have baseline TARC and 6 did not have TARC prior to cycle 2.

Limit to 41 evaluable patients who received dose 1.8 mg/kg

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=41 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
Plasma Level of Thymus and Activation-Regulated Chemokine (TARC) Baseline	5700 pg/ml Interval 389.0 to	—
Plasma Level of Thymus and Activation-Regulated Chemokine (TARC) Prior to Cycle 2	668 pg/ml Interval 6.0 to	—

SECONDARY outcome

Timeframe: From the end of first dose to the end of last dose (Up to 13 Months)

Population: These samples were banked but not analyzed, due to a change in research priorities.

Limit to 41 evaluable patients who received dose 1.8 mg/kg

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the end of first dose to the end of last dose (Up to 13 Months)

Population: 4 eligible patients did not consent for genetic studies.

Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described.

Outcome measures

Outcome measures
Measure	Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride) n=41 Participants Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg (Phase I + Phase II) Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism Heterozygous FV- Valine/Phenylalanine	14 Participants	—
Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism Homozygous FF- Phenylalanine	22 Participants	—
Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism Homozygous VV- Valine	5 Participants	—

Adverse Events

Dose1.4mg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose 1.8mg/kg

Serious events: 37 serious events

Other events: 28 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	Dose1.4mg/kg n=3 participants at risk Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV	Dose 1.8mg/kg n=42 participants at risk Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	14.3% 6/42 • Number of events 6 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Cardiac disorders Chest pain - cardiac	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Cardiac disorders Pericardial effusion	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Ear and labyrinth disorders Ear and labyrinth disorders - Other- Specify	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/42 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Eye disorders Photophobia	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	7.1% 3/42 • Number of events 3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Constipation	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	9.5% 4/42 • Number of events 4 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	21.4% 9/42 • Number of events 9 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	19.0% 8/42 • Number of events 8 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Chills	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	19.0% 8/42 • Number of events 8 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Fever	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	19.0% 8/42 • Number of events 8 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders General disorders and administration site conditions - Other- Specify	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Malaise	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Lung infection	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Phlebitis infective	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Vaginal infection	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	21.4% 9/42 • Number of events 9 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Alkaline phosphatase increased	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	16.7% 7/42 • Number of events 7 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	23.8% 10/42 • Number of events 10 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Blood bilirubin increased	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Carbon monoxide diffusing capacity decreased	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations CPK increased	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/42 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Creatinine increased	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Forced expiratory volume decreased	33.3% 1/3 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/42 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations INR increased	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	2.4% 1/42 • Number of events 1 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Investigations Investigations - Other- Specify	0.00% 0/3 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.	4.8% 2/42 • Number of events 2 • From first dose up to 13 months. Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.