Trial Outcomes & Findings for Trial of TRC105 and Sorafenib in Patients With HCC (NCT NCT02560779)
NCT ID: NCT02560779
Last Updated: 2020-07-17
Results Overview
If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC105 during the first 4 months of participation in the trial. The number of DLTs by dose cohort have been presented.
COMPLETED
PHASE1/PHASE2
27 participants
4 months
2020-07-17
Participant Flow
Participant milestones
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of TRC105 and Sorafenib in Patients With HCC
Baseline characteristics by cohort
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=14 Participants
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=13 Participants
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Patients must have received at least a portion of a dose of TRC105 or sorafenib to be evaluable for assessment of DLT.
If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC105 during the first 4 months of participation in the trial. The number of DLTs by dose cohort have been presented.
Outcome measures
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=14 Participants
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=13 Participants
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Number of Patients Who Experience Dose Limiting Toxicities by Dose Level
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Patients must have had a screening scan and at least 1 on study scan to be eligible for RECIST 1.1 evaluation.
Number of patients with a response (PR or CR) are included by dose level. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients must have had a screening scan and at least 1 on study scan to be eligible for RECIST 1.1 evaluation.
Outcome measures
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=14 Participants
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=11 Participants
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: Steady state mean trough serum concentration by dose level after 5 weeks of dosing. Patients must have received all protocol required TRC105 doses to be included in the analysis. Additional analysis were not performed as TRC105 development overall was canceled due to lack of efficacy.
Steady state mean trough serum concentrations by dose level of TRC105 after 5 weeks of dosing were measured using validated methods after 5 weeks of dosing.
Outcome measures
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=8 Participants
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=3 Participants
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Pharmacokinetic Profile of TRC105 When Given With Sorafenib
|
14.2 ug/ML
Standard Deviation 12.1
|
44.7 ug/ML
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: Number of patients who tested positive for antibodies to TRC105. Patients must have tested negative for TRC105 antibodies at baseline and have had an on study test performed to be included in the analysis.
Number of patients who tested positive for antibodies to TRC105 by dose level. Anti-Product Antibody (APA) concentrations were measured using validated ELISA methods.
Outcome measures
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=13 Participants
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=5 Participants
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA)
|
9 Participants
|
5 Participants
|
Adverse Events
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
Serious adverse events
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=14 participants at risk
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=13 participants at risk
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Aspartate Aminotransferase Increase
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Hepatobiliary disorders
Cholangitis
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Epstaxis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Wound Infection
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
Other adverse events
| Measure |
Carotuximab (10 mg/kg wk to 15 mg/kg Bi-wk) Plus Sorafenib
n=14 participants at risk
Carotuximab (TRC105) given weekly (10 mg/kg) for 2 cycles then bi-weekly iv TRC105 (15 mg/kg) with 400mg sorafenib twice daily
|
Carotuximab (10 mg/kg Weekly) Plus Sorafenib
n=13 participants at risk
Carotuximab (TRC105) given weekly iv (10 mg/kg) with 400mg sorafenib twice daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
38.5%
5/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Alanine Aminotransferase Increased
|
21.4%
3/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Ammonia Increased
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
6/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
46.2%
6/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Anxiety
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Asthenia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Bacteraemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
21.4%
3/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Amylase Increased
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Bilirubin Increased
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Blood Phosphorus Decreased
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Chest Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Chills
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
53.8%
7/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
46.2%
6/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
35.7%
5/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
53.8%
7/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
69.2%
9/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Immune system disorders
Drug Hypersensitivity
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
38.5%
5/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Dysuria
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
64.3%
9/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
84.6%
11/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Eye disorders
Eye Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Fatigue
|
50.0%
7/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
100.0%
13/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Vascular disorders
Flushing
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Gait Disturbance
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
38.5%
5/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Headache
|
42.9%
6/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
84.6%
11/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Vascular disorders
Hypertension
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
61.5%
8/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Irritability
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Laceration
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Lip Swelling
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Lipase Increased
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Malaise
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Medical Device Site Bruise
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Melaena
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Mucosal Inflammation
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
38.5%
5/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Neuropathy Peripheral
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Odynophagia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Oedema Peripheral
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Blistering
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
28.6%
4/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
42.9%
6/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
61.5%
8/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Periodontal Disease
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Eye disorders
Photopsia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Platelet Count Decreased
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
General disorders
Pyrexia
|
35.7%
5/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
30.8%
4/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
35.7%
5/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Rectal Ulcer
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Scrotal Infection
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Sinus Tachycardia
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Sinusitis
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Skin Papilloma
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Subcutaneous Abscess
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Reproductive system and breast disorders
Testicular Swelling
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Tremor
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Upper Respiratory Infection
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
0.00%
0/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Weight Decreased
|
14.3%
2/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
23.1%
3/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
Weight Increased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
15.4%
2/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/14 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
7.7%
1/13 • Adverse events were collected while on study and for 28 days following the last dose of TRC105 or sorafenib. The longest duration of participation of any patient on study was 24 months.
Only patients who received at least a portion of a dose of TRC105 or sorafenib were included in the safety population. Both dose groups received 10 mg/kg TRC105 for the first month. Patients assigned to the 10 mg/kg weekly (cycle 1) then 15 mg/kg every two weeks (cycle 2+) dose group who discontinued the study prior to initiating cycle 2 dosing were counted in the 10 mg/kg weekly adverse event group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place