Trial Outcomes & Findings for Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma (NCT NCT01817751)
NCT ID: NCT01817751
Last Updated: 2024-07-17
Results Overview
Number of patients evaluable for response, regardless of tumor platelet derived growth factor receptor (PDGFR) status, with 6- month PFS defined as the time from the first day a patient receives study treatment until time of progression per response assessment in neuro-oncology (RANO) or Macdonald criteria or death, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma
Baseline characteristics by cohort
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber of patients evaluable for response, regardless of tumor platelet derived growth factor receptor (PDGFR) status, with 6- month PFS defined as the time from the first day a patient receives study treatment until time of progression per response assessment in neuro-oncology (RANO) or Macdonald criteria or death, whichever occurs first.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants With 6-Month Progression Free Survival (PFS)
Met 6 month PFS
|
8 Participants
|
|
Number of Participants With 6-Month Progression Free Survival (PFS)
Did not meet 6 month PFS
|
25 Participants
|
|
Number of Participants With 6-Month Progression Free Survival (PFS)
Not Evaluable
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsNumber of patients evaluable for response, with tumors that express PDGFRα, with 6-month PFS defined as the time from the first day a patient receives study treatment until time of progression per RANO or Macdonald criteria or death, whichever occurs first.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=33 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Express PDGFRa that met 6 month PFS
|
5 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Express PDGFRa that did not meet 6 month PFS
|
7 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Did not express PDGFRa that met 6 month PFS
|
2 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Did not express PDGFRa that did not met 6 months
|
7 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Not evaluable
|
12 Participants
|
SECONDARY outcome
Timeframe: From the first day of study treatment until best response or off study, up to 4 yearsOverall response rate (CR+PR), using RANO or Macdonald criteria, in patients evaluable for response regardless of tumor PDGFR status
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.
# Pts with best response of CR
|
0 Participants
|
|
Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.
# Pts with best response of PR
|
1 Participants
|
|
Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.
# Pts without best response of PR or CR
|
32 Participants
|
|
Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.
# Pts not evaluable
|
14 Participants
|
SECONDARY outcome
Timeframe: From initiation of study treatment to time of best response or off-study (up to 4 years)Overall response rate (CR+PR), using RANO or Macdonald criteria, in patients who are evaluable for response and who have tumors that express PDGFRα.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=17 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
# Pts with best response of CR
|
0 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
# Pts with best response of PR
|
0 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
# Pts without best response of PR or CR
|
12 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
# Pts not evaluable
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of patients evaluable for response, regardless of tumor PDGFR status, who are alive at 12 months after the first day a patient receives study treatment. Overall Survival (OS) defined as the time from the first day a patient receives study treatment until death by any cause.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants With 12-Month Overall Survival (OS)
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsNumber of patients evaluable for response with tumors that express PDGFRα who are alive at 12 months after the first day a patient receives study treatment. On study is defined as the time from the first day a patient receives study treatment until death by any cause.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=33 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Expressed PDGFRa with12 month OS
|
6 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Expressed PDGFRa with less than 12 month survival
|
6 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Negative for PDGFRa with 12 month OS
|
3 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Negative for PDGFRa without 12 month OS
|
6 Participants
|
|
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Not Evaluable
|
12 Participants
|
SECONDARY outcome
Timeframe: From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment, up to 7 years.Number of patients with adverse events
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 Participants
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Evaluation of Safety and Toxicity of Sorafenib, Valproic Acid, and Sildenafil
|
47 Participants
|
Adverse Events
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
Serious events: 17 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 participants at risk
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
abdominal Pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
Colonic Perforation
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
ileal fistula
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
pancreatitis
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Hepatobiliary disorders
edema Limbs
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
Fatigue
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
gait disturbance
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
general disorders and administration site conditions
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
multi-organ failure
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
appendicitis
|
2.1%
1/47 • Number of events 47 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
fall
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
fracture
|
2.1%
1/47 • Number of events 47 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
alanine aminotransferase increased
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
aspartate aminotransferase increased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
investigations-other, specify
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
lipase increased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
neutrophil count decreased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
Platelet count decreased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
White blood cell decreased
|
2.1%
1/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
dehydration
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.1%
1/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
muscle weakness, right-sided
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
concentration impairment
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dysphasia
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
hypersomnia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
lethargy
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
seizure
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
somnolence
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
confusion
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
hematuria
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
renal calculi
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary incontinence
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Social circumstances
social circumstances-other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
hematoma
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
hypotension
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
thromboembolic event
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
Other adverse events
| Measure |
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
n=47 participants at risk
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
40.4%
19/47 • Number of events 22 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Cardiac disorders
atrial fibrillation
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Cardiac disorders
cardiac disorders-other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Cardiac disorders
sinus bradycardia
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Cardiac disorders
sinus tachycardia
|
10.6%
5/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Ear and labyrinth disorders
ear and labyrinth disorders-other, specify
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Ear and labyrinth disorders
hearing impaired
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Ear and labyrinth disorders
tinnitus
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Ear and labyrinth disorders
vertigo
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Endocrine disorders
cushingoid
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Endocrine disorders
endocrine disorders-other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Endocrine disorders
hyperthyroidism
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Eye disorders
blurred vision
|
17.0%
8/47 • Number of events 10 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Eye disorders
eye disorders-other, specify
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Eye disorders
eye pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Eye disorders
watering eyes
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
abdominal distension
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
abdominal pain
|
17.0%
8/47 • Number of events 12 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
bloating
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
constipation
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
diarrhea
|
44.7%
21/47 • Number of events 34 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
dry mouth
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
dyspepsia
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
dysphagia
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
fecal incontinence
|
14.9%
7/47 • Number of events 10 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
flatulence
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
12.8%
6/47 • Number of events 9 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
12.8%
6/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.1%
1/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
mucositis oral
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
nausea
|
23.4%
11/47 • Number of events 12 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
oral dysesthesia
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
oral hemorrhage
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
toothache
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
vomiting
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
edema face
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
edema limbs
|
12.8%
6/47 • Number of events 9 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
fatigue
|
55.3%
26/47 • Number of events 34 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
fever
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Gastrointestinal disorders
gait disturbance
|
27.7%
13/47 • Number of events 14 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
Generalized edema
|
2.1%
1/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
irritability
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
malaise
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
non-cardiac chest pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
General disorders
pain
|
12.8%
6/47 • Number of events 12 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Immune system disorders
allergic reaction
|
4.3%
2/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
eye infection
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
infections and infestations-other, specify
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
mucosal infection
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
nail infection
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
otitis media
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
papulopustular rash
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
pharyngitis
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
prostate infection
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
skin infection
|
6.4%
3/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
soft tissue infection
|
2.1%
1/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Infections and infestations
urinary tract infection
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
bruising
|
23.4%
11/47 • Number of events 19 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
wound complication
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
Alanine aminotransferase increased
|
36.2%
17/47 • Number of events 23 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
alkaline phosphatase increased
|
6.4%
3/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
aspartate aminotransferase increased
|
34.0%
16/47 • Number of events 22 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
blood bilirubin increased
|
8.5%
4/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
cholesterol high
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
creatinine increased
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
GGT increased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
hemoglobin increased
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
investigations - other, specify
|
17.0%
8/47 • Number of events 17 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
lymphocyte count decreased
|
46.8%
22/47 • Number of events 36 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
neutrophil count decreased
|
42.6%
20/47 • Number of events 33 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
platelet count decreased
|
68.1%
32/47 • Number of events 48 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
weight gain
|
4.3%
2/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
weight loss
|
12.8%
6/47 • Number of events 13 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Investigations
white blood cell decreased
|
46.8%
22/47 • Number of events 36 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
anorexia
|
27.7%
13/47 • Number of events 16 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
dehydration
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
glucose intolerance
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hyperglycemia
|
8.5%
4/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hyperkalemia
|
21.3%
10/47 • Number of events 12 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypernatremia
|
6.4%
3/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
42.6%
20/47 • Number of events 26 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypocalcemia
|
55.3%
26/47 • Number of events 41 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypoglycemia
|
8.5%
4/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypokalemia
|
27.7%
13/47 • Number of events 28 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.9%
7/47 • Number of events 10 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hyponatremia
|
29.8%
14/47 • Number of events 19 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
74.5%
35/47 • Number of events 63 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.1%
1/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
4.3%
2/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.5%
4/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
buttock pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
chest wall pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
19.1%
9/47 • Number of events 13 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased
|
2.1%
1/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
muscle weakness left-sided
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
muscle weakness lower limb
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
muscle weakness right-sided
|
4.3%
2/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
muscle weakness upper limb
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
8.5%
4/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.3%
2/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
cognitive disturbance
|
6.4%
3/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
concentration impairment
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
depressed level of consciousness
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dizziness
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dysarthria
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dysesthesia
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dysgeusia
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
dysphasia
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
edema cerebral
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
encephalopathy
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
facial muscle weakness
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
headache
|
25.5%
12/47 • Number of events 19 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
hypersomnia
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
intracranial hemorrhage
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
ischemia cerebrovascular
|
2.1%
1/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
lethargy
|
14.9%
7/47 • Number of events 11 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
memory impairment
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
nervous system disorders- other, specify
|
17.0%
8/47 • Number of events 9 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
paresthesia
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
peripheral sensory neuropathy
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
presyncope
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
seizure
|
10.6%
5/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
sinus pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
somnolence
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
spasticity
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Nervous system disorders
tremor
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
Agitation
|
12.8%
6/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
anxiety
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
confusion
|
31.9%
15/47 • Number of events 18 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
delusions
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
depression
|
4.3%
2/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
hallucinations
|
6.4%
3/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
insomnia
|
17.0%
8/47 • Number of events 9 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
personality change
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
psychiatric disorders- other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Psychiatric disorders
suicidal ideation
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
hematuria
|
10.6%
5/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
proteinuria
|
8.5%
4/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
renal calculi
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary frequency
|
12.8%
6/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary incontienence
|
19.1%
9/47 • Number of events 11 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary retention
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary tract pain
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Renal and urinary disorders
urinary urgency
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Reproductive system and breast disorders
genital edema
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
17.0%
8/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
12.8%
6/47 • Number of events 7 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
10.6%
5/47 • Number of events 6 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
8.5%
4/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
alopecia
|
14.9%
7/47 • Number of events 8 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
body odor
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
dry skin
|
17.0%
8/47 • Number of events 9 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
pain of skin
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
palmar-plantar erythrodysesthesia syndrome
|
42.6%
20/47 • Number of events 55 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
pruritus
|
10.6%
5/47 • Number of events 5 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
purpura
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
36.2%
17/47 • Number of events 22 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
scalp pain
|
8.5%
4/47 • Number of events 4 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders- other, specify
|
21.3%
10/47 • Number of events 24 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
skin ulceration
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
flushing
|
36.2%
17/47 • Number of events 18 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
hematoma
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
hypertension
|
40.4%
19/47 • Number of events 44 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
hypotension
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Vascular disorders
thromboembolic event
|
4.3%
2/47 • Number of events 2 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
fall
|
25.5%
12/47 • Number of events 24 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
fracture
|
2.1%
1/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other, specify
|
6.4%
3/47 • Number of events 3 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
2.1%
1/47 • Number of events 1 • From initiation of study therapy to completion of adverse event (AE) observation period, up to 30 days following the end of study treatment up to 7 years.
Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
|
Additional Information
Massey Cancer Center CTO Operations Managers
Virginia Commonwealth University Massey Cancer Center
Phone: 877-4627739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place