Trial Outcomes & Findings for Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma (NCT NCT01313884)

Last Updated: 2017-11-24

Results Overview

Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2017-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Therapy Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Therapy Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS
Overall Study Per insurance pvdr, pt can't be on cl tr	1

Baseline Characteristics

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy n=3 Participants Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Outcome measures

Outcome measures
Measure	Combination Therapy n=2 Participants Regimen A alternating with Regimen B every 21 days Regimen A: * Cytoxan 1200mg/m2 * Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2 * Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg * Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle Regimen B: * Irinotecan 50 mg/m2/day x 5 days * Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Overall Response Rate (Partial and Complete Response) Complete Response	0 Participants
Overall Response Rate (Partial and Complete Response) Partial Response	2 Participants

SECONDARY outcome

Timeframe: 24 months

Population: All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data.

The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.

Outcome measures

Outcome data not reported

Adverse Events

Combination Therapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Therapy n=3 participants at risk Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Dehydration	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Fever	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.

Other adverse events

Other adverse events
Measure	Combination Therapy n=3 participants at risk Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS
General disorders Intermittent headache G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Decreased energy G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Fatigue G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Insomnia G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Insomnia G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Fever G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Hiccups G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Throat pain G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Nausea G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Nausea, intermittent G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Nausea, intermittent G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Mucositis oral G1	66.7% 2/3 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Oral lesions G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders oral candidiasis G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Sore throat G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Pain with swallowing G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Worsening acid reflux G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Diarrhea G1	66.7% 2/3 • Number of events 3 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Abdominal cramping G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Abdominal pain G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Intermittent diarrhea G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Vomiting G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Vomiting intermittent G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Constipation G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Gastrointestinal disorders Nausea and vomiting G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Anemia G2	33.3% 1/3 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Worsened anemia G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Anemia G3	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Decreased neutrophils G4	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Infection-staph epidermis bacteremia	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Platelet count decreased G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Metabolism and nutrition disorders Hypokalemia G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Metabolism and nutrition disorders Hypocalcemia intermittent G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Metabolism and nutrition disorders Hyponatremia intermittent G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Platelet count decreased G2	33.3% 1/3 • Number of events 2 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders Platelet count decreased G4	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Metabolism and nutrition disorders Intermittent hypoglycemia G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders White blood cells decreased G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Blood and lymphatic system disorders White blood cells decreased G4	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Metabolism and nutrition disorders Hypomagnesemia G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Musculoskeletal and connective tissue disorders Hip pain L G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Musculoskeletal and connective tissue disorders Pain sacrum (tailbone) G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Musculoskeletal and connective tissue disorders Pain left leg G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Musculoskeletal and connective tissue disorders Pain-lowe leg, back G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
General disorders Pain generalized 2-3 days post neulasta G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Nervous system disorders Tingling at left toes G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Nervous system disorders Numbness on left shin G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Respiratory, thoracic and mediastinal disorders Cough G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Onychomycosis G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Hip abscess G3	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Erythema L hip G2	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Erythema groin crease G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Erythema left leg G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Edema left leg pitting 2+, G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Skin and subcutaneous tissue disorders Hyperpigmentation left knee G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Eye disorders Disc edema R eye G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.
Respiratory, thoracic and mediastinal disorders Rhinorrhea G1	33.3% 1/3 • Number of events 1 • All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. Patients were asked about adverse events at every clinic visit.

Additional Information

Kristen Ganjoo, MD

Stanford University Medical Center

Phone: 650-725-6413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place