Trial Outcomes & Findings for Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD) (NCT NCT01954979)

NCT ID: NCT01954979

Last Updated: 2026-05-29

Results Overview

The study will follow a standard 3+3 design with two escalating doses of abatacept to determine the maximum tolerated dose (MTD): 3 mg/kg (dose level 1) and 10 mg/kg (dose level 2). Dose-limiting toxicities (DLTs) are defined as any Grade 3 or 4 toxicities judged to be probably or definitely related to abatacept.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

56 participants

Primary outcome timeframe

The first 8 weeks of treatment

Results posted on

2026-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 Dose Level 1 (3mg/kg) 3 subjects were enrolled at a dose of 3 mg/kg	Phase I Dose Level 2 (10 mg/kg) 3 patients were enrolled at a dose of 10 mg/kg. No DLTs were experienced so an additional 10 subjects were enrolled at the 10mg/kg dose.	Phase 2 Expansion (10 mg/kg) Following completion of phase 1, 39 subjects were enrolled to the phase 2 portion of the study and treated with a dose of 10mg/kg.
Overall Study STARTED	3	14	39
Overall Study COMPLETED	3	13	39
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Level 1 (3 mg/kg) n=3 Participants 3 subjects were enrolled to receive Abatacept at a dose of 3 mg/kg.	Phase 1 Dose Level 2 (10mg/kg) n=13 Participants 3 subjects were enrolled to receive Abatacept at a dose of 10 mg/kg. No DLTs were experienced so an additional 10 subjects were enrolled at the 10mg/kg dose.	Phase 2 Expansion (10mg/kg) n=39 Participants Following completion of phase 1, 39 subjects were enrolled to the phase 2 portion of the study and treated with a dose of 10mg/kg.	Total n=55 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=51 Participants	10 Participants n=14 Participants	25 Participants n=65 Participants	37 Participants n=57 Participants
Age, Categorical >=65 years	1 Participants n=51 Participants	3 Participants n=14 Participants	14 Participants n=65 Participants	18 Participants n=57 Participants
Age, Continuous	53 years n=51 Participants	59 years n=14 Participants	62 years n=65 Participants	58 years n=57 Participants
Sex: Female, Male Female	2 Participants n=51 Participants	5 Participants n=14 Participants	21 Participants n=65 Participants	28 Participants n=57 Participants
Sex: Female, Male Male	1 Participants n=51 Participants	8 Participants n=14 Participants	18 Participants n=65 Participants	27 Participants n=57 Participants
Race (NIH/OMB) Asian	0 Participants n=51 Participants	0 Participants n=14 Participants	2 Participants n=65 Participants	2 Participants n=57 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Black or African American	0 Participants n=51 Participants	0 Participants n=14 Participants	1 Participants n=65 Participants	1 Participants n=57 Participants
Race (NIH/OMB) White	3 Participants n=51 Participants	13 Participants n=14 Participants	36 Participants n=65 Participants	52 Participants n=57 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants	0 Participants n=57 Participants
Region of Enrollment United States	3 participants n=51 Participants	13 participants n=14 Participants	39 participants n=65 Participants	55 participants n=57 Participants

PRIMARY outcome

Timeframe: The first 8 weeks of treatment

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 (3mg/kg) n=3 Participants 3 subjects were enrolled to receive Abatacept at a dose of 3 mg/kg	Phase 1 Dose Level 2 (10mg/kg) n=3 Participants In the Phase 1 portion of the study, 3 patients were treated with 10mg/kg dose	Phase 2 (MTD: 10mg/kg) n=10 Participants Once the MTD was noted to be 10mg/kg, an additional 10 patients were treated at this dose.
Number of Participants With Dose-Limiting Toxicities (DLTs) # of Patients Who Completed At Least 8 Weeks of Treatment	3 participants	3 participants	10 participants
Number of Participants With Dose-Limiting Toxicities (DLTs) # of Patients Who Experienced a DLT	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 month following 6th dose of abatacept

Population: In total, 36 patients were included in the analysis of cGVHD response. We analyzed chronic GVHD response according to the 2011 NIH Chronic GVHD Consensus Response Criteria. The following are number of participants that achieved a clinical partial response (PR). Partial response (PR) is defined by improvement of two disease systems based on the 2011 NIH consensus criteria.

Following identification of MTD, the study expanded to a phase 2 cohort. One outcome of the phase 2 cohort was efficacy. Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 (3mg/kg) n=36 Participants 3 subjects were enrolled to receive Abatacept at a dose of 3 mg/kg	Phase 1 Dose Level 2 (10mg/kg) In the Phase 1 portion of the study, 3 patients were treated with 10mg/kg dose	Phase 2 (MTD: 10mg/kg) Once the MTD was noted to be 10mg/kg, an additional 10 patients were treated at this dose.
Determination of the Efficacy of a 141 Day/6 Dose Course of Abatacept in Patients With Steroid Refractory cGVHD (Phase 2 Cohort Only) Responders (Participants Achieving PR)	21 Participants	—	—
Determination of the Efficacy of a 141 Day/6 Dose Course of Abatacept in Patients With Steroid Refractory cGVHD (Phase 2 Cohort Only) Non responders (Patients with no response)	15 Participants	—	—

SECONDARY outcome

Timeframe: 1 month after 6th dose of abatacept

Following identification of MTD, the study expanded to a phase 2 cohort. One outcome of the phase 2 cohort was immunologic effects of abatacept. This was evaluated through flow cytometry to measure changes in % of cells expressing CD4 and PD1.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 (3mg/kg) n=19 Participants 3 subjects were enrolled to receive Abatacept at a dose of 3 mg/kg	Phase 1 Dose Level 2 (10mg/kg) In the Phase 1 portion of the study, 3 patients were treated with 10mg/kg dose	Phase 2 (MTD: 10mg/kg) Once the MTD was noted to be 10mg/kg, an additional 10 patients were treated at this dose.
Examination of the Immunologic Effects (Changes in % of Cells Expressing CD4 and PD1) Associated With the Administration of Abatacept in Patients With Steroid Refractory cGVHD (Phase 2 Cohort Only) % of CD4+/ PD1+ Cells at Baseline	33.12 % of CD4+/ PD1+ Standard Deviation 10.34	—	—
Examination of the Immunologic Effects (Changes in % of Cells Expressing CD4 and PD1) Associated With the Administration of Abatacept in Patients With Steroid Refractory cGVHD (Phase 2 Cohort Only) % of CD4+/ PD1+ Cells 1 month following 6 doses	26.59 % of CD4+/ PD1+ Standard Deviation 12.92	—	—

Adverse Events

Phase 1 Dose Level 1 (3 mg/kg)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 1 Dose Level 2 (10 mg/kg)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase 2 Expansion (10 mg/kg)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Dose Level 1 (3 mg/kg) n=3 participants at risk 3 subjects were enrolled at a dose of 3 mg/kg. No DLTs were experienced.	Phase 1 Dose Level 2 (10 mg/kg) n=13 participants at risk 4 were enrolled at a dose of 10 mg/kg. No DLTs were experienced so an additional 10 subjects were enrolled at the 10mg/kg dose. One of the initial 4 participants withdrew consent and is not evaluable therefore not included in analysis.	Phase 2 Expansion (10 mg/kg) n=39 participants at risk Following completion of phase 1, 39 subjects were enrolled to the phase 2 portion of the study and treated with a dose of 10mg/kg.
Infections and infestations INFECTION, LUNG	33.3% 1/3 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	15.4% 2/13 • Number of events 4 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	5.1% 2/39 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Upper Respiratory Infection	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Investigations Elevated ALT	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Blood and lymphatic system disorders Hemolysis	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Sepsis	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Hepatic Infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Hepatobiliary disorders Hepatic Failure	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.

Other adverse events

Additional Information

Emma Logan, Director of Nursing

Beth Israel Deaconess Medical Center

Phone: 6176675984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1 Dose Level 1 (3 mg/kg) n=3 participants at risk 3 subjects were enrolled at a dose of 3 mg/kg. No DLTs were experienced.	Phase 1 Dose Level 2 (10 mg/kg) n=13 participants at risk 4 were enrolled at a dose of 10 mg/kg. No DLTs were experienced so an additional 10 subjects were enrolled at the 10mg/kg dose. One of the initial 4 participants withdrew consent and is not evaluable therefore not included in analysis.	Phase 2 Expansion (10 mg/kg) n=39 participants at risk Following completion of phase 1, 39 subjects were enrolled to the phase 2 portion of the study and treated with a dose of 10mg/kg.
Infections and infestations Urinary Tract Infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Gastrointestinal disorders Oral Pain	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Viral Upper Respiratory Infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
General disorders Pain	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Investigations Decreased ANC	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	10.3% 4/39 • Number of events 7 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
General disorders Fatigue	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	15.4% 2/13 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	17.9% 7/39 • Number of events 9 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
General disorders Headache	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 3/39 • Number of events 4 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Upper Respiratory Infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 3/39 • Number of events 3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Investigations AST Increase	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	5.1% 2/39 • Number of events 3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Investigations ALT Increase	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 3/39 • Number of events 3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Lung Infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	5.1% 2/39 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Infections and infestations Eye infection	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 4 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	10.3% 4/39 • Number of events 4 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Immune system disorders Flu-like symptoms	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	5.1% 2/39 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Renal and urinary disorders Cystitis, Noninfective	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	2.6% 1/39 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	5.1% 2/39 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/13 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Skin and subcutaneous tissue disorders Edema, skin	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 2 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.
General disorders Malaise	0.00% 0/3 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	7.7% 1/13 • Number of events 1 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.	0.00% 0/39 • Adverse event data was collected from the beginning of treatment through 6 months after the last dose. For the majority of patients this period was 1 year.