Trial Outcomes & Findings for Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (NCT NCT00324987)

Last Updated: 2017-09-14

Results Overview

From date of registration (defined as date of randomization) to date of first observation of progressive disease, death due to any cause or symptomatic deterioration. Patients last known to be alive and progression free are censored at last date of contact. Progression is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), provided at least one target lesion does NOT demonstrate uniform hypoattenuation over \> 90% of maximal cross sectional area; unequivocal progression of non-measurable disease; appearance of new lesion/site that is not uniformly hypoattenuating; a hyperattenuating region within a previously cystic/uniformly hypoattenuating lesion will be considered progressive disease if hyperattenuating region is either \>= 1 cm in longest diameter or round/oval and forms acute margins with border of target lesion; death due to disease.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Up to 7 years

Results posted on

2017-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Imatinib + Bevacizumab Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	6	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Imatinib + Bevacizumab Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	1	1
Overall Study Progression	1	1
Overall Study symptomatic deterioration, toxicity, etc	2	3

Baseline Characteristics

Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib + Bevacizumab n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Total n=12 Participants Total of all reporting groups
Age, Continuous	64.7 years n=5 Participants	57.9 years n=7 Participants	59.9 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Performance Status 0	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Performance Status >=1	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Disease Status Measurable	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Disease Status Non-measurable	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Population: No scientific conclusions were forthcoming because of the small number of patients entered in the study.

Outcome measures

Outcome measures
Measure	Imatinib + Bevacizumab n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival	30 months Interval 8.0 to 62.0	81 months Interval 13.0 to 81.0

SECONDARY outcome

Timeframe: Up to 7 years

Population: Only eligible and evaluable patients included. No scientific conclusions were forthcoming because of the small number of patients entered in the study.

Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Outcome measures

Outcome measures
Measure	Imatinib + Bevacizumab n=3 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=5 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Response Rate Unconfirmed CR	0 Participants	1 Participants
Response Rate Stable/No Response	1 Participants	2 Participants
Response Rate Assessment Inadequate	2 Participants	2 Participants

SECONDARY outcome

Timeframe: up to 7 years

Population: No scientific conclusions were forthcoming because of the small number of patients entered in the study.

From date of registration (defined as date of randomization) to date of death due to any cause. Patients last known to be alive are censored at last date of contact. Note: median was not reached in the Imatinib arm due to limited follow-up data.

Outcome measures

Outcome measures
Measure	Imatinib + Bevacizumab n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	30 months Interval 16.0 to 30.0	0 months Interval 15.0 to 0.0

SECONDARY outcome

Timeframe: up to 7 years

Population: Data not collected as study accrued only 2% of the 572 patients planned. No scientific conclusions were forthcoming because of the small number of patients entered in the study.

From date of registration (defined as date of randomization) to date of first documentation of one of the following events: death; first documentation of progression based on central review of the appropriate computed tomography (CT) or magnetic resonance imaging (MRI) scans; development of new lesions or disease not identified on CT or MRI; or symptomatic deterioration. Patients not experiencing any of these events will be censored at last date of contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 7 years

Population: Eligible patients who received any treatment and were assessed for adverse events are included in this summary.

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Imatinib + Bevacizumab n=5 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 Participants Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug INR (of prothrombin time)	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemoglobin	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hemorrhage, GI - Upper GI NOS	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Proteinuria	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thrombosis/embolism (vascular access-related)	0 Participants	1 Participants

Adverse Events

Imatinib + Bevacizumab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Imatinib

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib + Bevacizumab n=5 participants at risk Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 participants at risk Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Hemorrhage, GI - Upper GI NOS	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Renal and urinary disorders Proteinuria	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Other adverse events

Additional Information

SWOG Statistician

SWOG Statistical Center

Phone: 206-667-4408

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Imatinib + Bevacizumab n=5 participants at risk Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Imatinib n=6 participants at risk Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	40.0% 2/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Cardiac disorders Palpitations	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Endocrine disorders Thyroid function, low (hypothyroidism)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Eye disorders Vision-blurred vision	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Constipation	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Hemorrhage, GI - Stomach	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Nausea	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Pain - Abdomen NOS	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Edema: head and neck	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Edema: limb	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Fatigue (asthenia, lethargy, malaise)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Rigors/chills	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Injury, poisoning and procedural complications Bruising (in absence of Gr 3-4 thrombocytopenia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations AST, SGOT	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Creatinine	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations INR (of prothrombin time)	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Leukocytes (total WBC)	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Neutrophils/granulocytes (ANC/AGC)	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Weight gain	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Weight loss	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Pain - Joint	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Pain - Muscle	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Dizziness	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Pain - Head/headache	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Tremor	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Renal and urinary disorders Proteinuria	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Hemorrhage, Respiratory tract NOS	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	0.00% 0/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Rash/desquamation	0.00% 0/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	16.7% 1/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Vascular disorders Hypertension	20.0% 1/5 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.	33.3% 2/6 • Up to 7 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.