Trial Outcomes & Findings for Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma (NCT NCT03224767)
NCT ID: NCT03224767
Last Updated: 2026-06-10
Results Overview
Defined as the number of responses achieved during treatment with BRAF and MEK inhibitors divided by the total number of evaluable patients and assessed by contrast-enhanced magnetic resonance imaging or computed tomography. Point estimates will be generated for response rates within each cohort with corresponding 95% binomial confidence intervals. Simon's two-stage design with one interim analysis for futility will be applied to evaluate response rate within each cohort.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2026-06-10
Participant Flow
Participant milestones
| Measure |
Arm A
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
For Cohort B, patients will receive 4 cycles of study drug therapy (unless progression, unacceptable toxicity, or patient withdrawal from treatment occurs). After 4 cycles of vemurafenib + cobimetinib, the patient may go on to receive treatment per the discretion of the treating physician, including radiation, surgery or continued treatment with vemurafenib + cobimetinib. Treatment with vemurafenib + cobimetinib can be continued until CR, PR, or SD but must be discontinued with PD. The BRAF and MEK inhibitors need to be stopped at least two weeks before initiation of radiation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
5
|
|
Overall Study
COMPLETED
|
16
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Baseline characteristics by cohort
| Measure |
Arm A
n=16 Participants
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 Participants
For Cohort B, patients will receive 4 cycles of study drug therapy (unless progression, unacceptable toxicity, or patient withdrawal from treatment occurs). After 4 cycles of vemurafenib + cobimetinib, the patient may go on to receive treatment per the discretion of the treating physician, including radiation, surgery or continued treatment with vemurafenib + cobimetinib. Treatment with vemurafenib + cobimetinib can be continued until CR, PR, or SD but must be discontinued with PD. The BRAF and MEK inhibitors need to be stopped at least two weeks before initiation of radiation therapy.\>
\> Quality-of-Life Assessment: Ancillary studies
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
n=9 Participants
|
44.0 years
n=27 Participants
|
48 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
ECOG Performance Status
0
|
15 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
ECOG Performance Status
1
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsDefined as the number of responses achieved during treatment with BRAF and MEK inhibitors divided by the total number of evaluable patients and assessed by contrast-enhanced magnetic resonance imaging or computed tomography. Point estimates will be generated for response rates within each cohort with corresponding 95% binomial confidence intervals. Simon's two-stage design with one interim analysis for futility will be applied to evaluate response rate within each cohort.
Outcome measures
| Measure |
Arm A
n=16 Participants
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 Participants
For Cohort B, patients will receive 4 cycles of study drug therapy (unless progression, unacceptable toxicity, or patient withdrawal from treatment occurs). After 4 cycles of vemurafenib + cobimetinib, the patient may go on to receive treatment per the discretion of the treating physician, including radiation, surgery or continued treatment with vemurafenib + cobimetinib. Treatment with vemurafenib + cobimetinib can be continued until CR, PR, or SD but must be discontinued with PD. The BRAF and MEK inhibitors need to be stopped at least two weeks before initiation of radiation therapy.
|
|---|---|---|
|
Response Rate
|
94 percentage of participants
Interval 70.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 1 yearWill be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates at 12 months
Outcome measures
| Measure |
Arm A
n=16 Participants
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 Participants
For Cohort B, patients will receive 4 cycles of study drug therapy (unless progression, unacceptable toxicity, or patient withdrawal from treatment occurs). After 4 cycles of vemurafenib + cobimetinib, the patient may go on to receive treatment per the discretion of the treating physician, including radiation, surgery or continued treatment with vemurafenib + cobimetinib. Treatment with vemurafenib + cobimetinib can be continued until CR, PR, or SD but must be discontinued with PD. The BRAF and MEK inhibitors need to be stopped at least two weeks before initiation of radiation therapy.
|
|---|---|---|
|
Progression-free Survival
|
0.87 proportion of participants
Interval 0.57 to 0.89
|
0.80 proportion of participants
Interval 0.52 to 1.0
|
SECONDARY outcome
Timeframe: Up to 1 yearWill be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates at 12 months.
Outcome measures
| Measure |
Arm A
n=16 Participants
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 Participants
For Cohort B, patients will receive 4 cycles of study drug therapy (unless progression, unacceptable toxicity, or patient withdrawal from treatment occurs). After 4 cycles of vemurafenib + cobimetinib, the patient may go on to receive treatment per the discretion of the treating physician, including radiation, surgery or continued treatment with vemurafenib + cobimetinib. Treatment with vemurafenib + cobimetinib can be continued until CR, PR, or SD but must be discontinued with PD. The BRAF and MEK inhibitors need to be stopped at least two weeks before initiation of radiation therapy.
|
|---|---|---|
|
Overall Survival
|
NA proportion of participants
There was an insufficient number of participants with events to calculate the median and confidence interval.
|
NA proportion of participants
There was an insufficient number of participants with events to calculate the median and confidence interval.
|
Adverse Events
Arm A
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm B
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=17 participants at risk
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
General disorders and administration site conditions
Fever
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Immune system disorders
Anaphylaxis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
ECG QT corrected interval prolonged
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
Other adverse events
| Measure |
Arm A
n=17 participants at risk
For Cohort A, patients should receive treatment for up to 4 cycles with vemurafenib + cobimetinib (unless progression, unacceptable toxicity, or patient withdrawal from study occurs). See Section 12.0 for additional information. After 4 cycles of vemurafenib and cobimetinib, surgery or radiation for definitive therapy should be performed. Continuation of vemurafenib and cobimetinib beyond 4 cycles in cohort A will require approval from the radiation oncology chair and study chair. If patient stays on study for longer than 4 cycles, visits and labs at the beginning of every cycle are still required with scans every 2 cycles, as per the study calendar.
|
Arm B
n=5 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
52.9%
9/17 • Number of events 37 • Up to 5 years
|
60.0%
3/5 • Number of events 23 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
17.6%
3/17 • Number of events 3 • Up to 5 years
|
20.0%
1/5 • Number of events 7 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
64.7%
11/17 • Number of events 34 • Up to 5 years
|
60.0%
3/5 • Number of events 24 • Up to 5 years
|
|
Investigations
CPK increased
|
58.8%
10/17 • Number of events 42 • Up to 5 years
|
100.0%
5/5 • Number of events 19 • Up to 5 years
|
|
Investigations
Cholesterol high
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Investigations
Creatinine increased
|
11.8%
2/17 • Number of events 3 • Up to 5 years
|
40.0%
2/5 • Number of events 7 • Up to 5 years
|
|
Investigations
ECG QT corrected interval prolonged
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Investigations
Investigations - Other, specify
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Investigations
Weight loss
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.5%
4/17 • Number of events 4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Up to 5 years
|
40.0%
2/5 • Number of events 6 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
17.6%
3/17 • Number of events 4 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
40.0%
2/5 • Number of events 5 • Up to 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
40.0%
2/5 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/17 • Up to 5 years
|
40.0%
2/5 • Number of events 6 • Up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
11.8%
2/17 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Up to 5 years
|
60.0%
3/5 • Number of events 7 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
47.1%
8/17 • Number of events 43 • Up to 5 years
|
40.0%
2/5 • Number of events 11 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.8%
2/17 • Number of events 4 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
82.4%
14/17 • Number of events 49 • Up to 5 years
|
40.0%
2/5 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
17.6%
3/17 • Number of events 11 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
17.6%
3/17 • Number of events 7 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Immune system disorders
Allergic reaction
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
17.6%
3/17 • Number of events 7 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
35.3%
6/17 • Number of events 12 • Up to 5 years
|
40.0%
2/5 • Number of events 7 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Retinopathy
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Uveitis
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
82.4%
14/17 • Number of events 49 • Up to 5 years
|
60.0%
3/5 • Number of events 15 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/17 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
General disorders and administration site conditions
Edema face
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
General disorders and administration site conditions
Edema limbs
|
5.9%
1/17 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
General disorders and administration site conditions
Fatigue
|
70.6%
12/17 • Number of events 75 • Up to 5 years
|
100.0%
5/5 • Number of events 25 • Up to 5 years
|
Additional Information
Dr. Priscilla K. Brastianos
Massachusetts General Hospital
Phone: 617-643-1938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place