Trial Outcomes & Findings for Evaluation of Votrient in Angiosarcoma (NCT NCT02212015)
NCT ID: NCT02212015
Last Updated: 2022-03-22
Results Overview
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
6 Month
Results posted on
2022-03-22
Participant Flow
Participant milestones
| Measure |
Pazopanib + Paclitaxel
Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.
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|---|---|
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Overall Study
STARTED
|
26
|
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Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
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|---|---|
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Age, Continuous
|
57.8 years
STANDARD_DEVIATION 13.5 • n=26 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=26 Participants
|
|
Subgroup 1 for Analyses
cutaneous angiosarcoma
|
18 Participants
n=26 Participants
|
|
Subgroup 1 for Analyses
visceral angiosarcoma
|
8 Participants
n=26 Participants
|
|
Subgroup 2 for Analyses
primary angiosarcoma
|
13 Participants
n=26 Participants
|
|
Subgroup 2 for Analyses
secondary angiosarcoma
|
13 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 6 MonthThe diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
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|---|---|
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Rate of Progression-free Survival
|
12 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Subgroup 1 (categorizing total number of 12 participants showing PFR survival after 6 months into cutaneous AS versus visceral AS)
Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=12 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Rate of Progression-free Survival, Subgroup 1 Analysis
cutaneous angiosarcoma
|
11 Participants
|
|
Rate of Progression-free Survival, Subgroup 1 Analysis
visceral angiosarcoma
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsRate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma. The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=12 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Rate of Progression-free Survival, Subgroup 2 Analysis
primary angiosarcoma
|
6 Participants
|
|
Rate of Progression-free Survival, Subgroup 2 Analysis
secondary angiosarcoma
|
6 Participants
|
SECONDARY outcome
Timeframe: from start of treatment until death within study's actual observation time for OS (22 months).Survival time of patient from start of treatment until death
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
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|---|---|
|
Overall Survival
|
21.6 months
Interval 20.5 to
The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.
|
SECONDARY outcome
Timeframe: from start of treatment until death within study's actual observation time for OS (22 months)Population: Overall number of participants analyzed is 26. Thereof, 18 show cutaneous angiosarcoma, and 8 show cutaneos angiosarcoma.
Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Overall Survival, Subgroup 1 Analysis
cutaneous angiosarcoma
|
21.6 months
Interval 10.0 to 21.6
|
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Overall Survival, Subgroup 1 Analysis
visceral angiosaroma
|
20.5 months
Interval 2.8 to
The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.
|
SECONDARY outcome
Timeframe: from start of treatment until death within study's actual observation time for OS (22 months)Population: Overall number of participants analyzed is 26. Thereof, 13 show cutaneous angiosarcoma, and 13 show cutaneos angiosarcoma
Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Overall Survival, Subgroup 2 Analysis
primary angiosarcoma
|
20.5 months
Interval 10.0 to
The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.
|
|
Overall Survival, Subgroup 2 Analysis
secondary angiosarcoma
|
21.6 months
The upper and lower bound of the 95% CI could not be estimated, because of too low number of events resulting in curves representing the upper as well as the lower limit of confidence interval lying above 0.5.
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SECONDARY outcome
Timeframe: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BORMeasurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Response Rate (RR)
CR
|
2 Participants
|
|
Response Rate (RR)
PR
|
7 Participants
|
|
Response Rate (RR)
SD
|
6 Participants
|
|
Response Rate (RR)
PD
|
10 Participants
|
|
Response Rate (RR)
NE
|
1 Participants
|
SECONDARY outcome
Timeframe: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BORPopulation: Total number of participants analyzed is 26. Thereof, 18 show cutaneous AS, and 8 show visceral angiosarcoma
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Response Rate (RR), Subgroup1 Analysis
cutaneous angiosarcoma · CR
|
2 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
cutaneous angiosarcoma · PR
|
6 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
cutaneous angiosarcoma · SD
|
4 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
cutaneous angiosarcoma · PD
|
6 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
cutaneous angiosarcoma · NE
|
0 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
visceral angiosarcoma · CR
|
0 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
visceral angiosarcoma · PR
|
1 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
visceral angiosarcoma · SD
|
2 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
visceral angiosarcoma · PD
|
4 Participants
|
|
Response Rate (RR), Subgroup1 Analysis
visceral angiosarcoma · NE
|
1 Participants
|
SECONDARY outcome
Timeframe: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BORPopulation: Total number of participants analyzed is 26. Thereof, 13 show primary angiosarcoma, and 13 show secondary angiosarcoma
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Response Rate (RR), Subgroup 2 Analysis
primary angiosarcoma · NE
|
0 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
secondary angiosarcoma · CR
|
2 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
primary angiosarcoma · CR
|
0 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
primary angiosarcoma · PR
|
5 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
primary angiosarcoma · SD
|
3 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
primary angiosarcoma · PD
|
5 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
secondary angiosarcoma · PR
|
2 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
secondary angiosarcoma · SD
|
3 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
secondary angiosarcoma · PD
|
5 Participants
|
|
Response Rate (RR), Subgroup 2 Analysis
secondary angiosarcoma · NE
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after EOS of last patient or end of overall study observation period (22 months)Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0
Outcome measures
| Measure |
Pazopanib + Paclitaxel
n=26 Participants
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Adverse Events and Serious Adverse Events
Patients with AEs
|
25 Participants
|
|
Adverse Events and Serious Adverse Events
Patients with SAEs
|
10 Participants
|
Adverse Events
Pazopanib + Paclitaxel
Serious events: 10 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pazopanib + Paclitaxel
n=26 participants at risk
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800 mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.
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|---|---|
|
Nervous system disorders
Lumbar spinal stenosis
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Cardiac disorders
Palpitation
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Infections and infestations
Erysipelas
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Cardiac disorders
Tachycardia
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Fever of unknown origin
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
ALT increased
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Reduced general condition
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Musculoskeletal and connective tissue disorders
Pain in thoracic spine
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
Bilirubin increased
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
GOT increased
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
GPT increased
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected over the study observation period which was 22 months
|
Other adverse events
| Measure |
Pazopanib + Paclitaxel
n=26 participants at risk
Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800 mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.
|
|---|---|
|
Hepatobiliary disorders
ALT increased
|
15.4%
4/26 • Number of events 12 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
AST increased
|
15.4%
4/26 • Number of events 12 • Adverse Events were collected over the study observation period which was 22 months
|
|
Product Issues
Allergic reation to a drug
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Reduced general condition
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.8%
8/26 • Number of events 9 • Adverse Events were collected over the study observation period which was 22 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.5%
3/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Musculoskeletal and connective tissue disorders
Inappetance
|
15.4%
4/26 • Number of events 4 • Adverse Events were collected over the study observation period which was 22 months
|
|
Vascular disorders
Hypertension
|
46.2%
12/26 • Number of events 17 • Adverse Events were collected over the study observation period which was 22 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
3/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Abdominal pain
|
19.2%
5/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Hepatobiliary disorders
Bilirubin increased
|
7.7%
2/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Diarrhea
|
61.5%
16/26 • Number of events 29 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.2%
5/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Nervous system disorders
Dysgeusia
|
42.3%
11/26 • Number of events 21 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • Number of events 4 • Adverse Events were collected over the study observation period which was 22 months
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Emesis
|
11.5%
3/26 • Number of events 8 • Adverse Events were collected over the study observation period which was 22 months
|
|
Infections and infestations
Acute nasopharyngitis
|
11.5%
3/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Infections and infestations
Erysipels
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
2/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Fever
|
15.4%
4/26 • Number of events 4 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Pain foot
|
15.4%
4/26 • Number of events 4 • Adverse Events were collected over the study observation period which was 22 months
|
|
Investigations
Weight loss
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
19.2%
5/26 • Number of events 11 • Adverse Events were collected over the study observation period which was 22 months
|
|
Cardiac disorders
Tachycardia
|
11.5%
3/26 • Number of events 5 • Adverse Events were collected over the study observation period which was 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
23.1%
6/26 • Number of events 28 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Meteorism
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Fatigue
|
46.2%
12/26 • Number of events 26 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Mucositis
|
15.4%
4/26 • Number of events 6 • Adverse Events were collected over the study observation period which was 22 months
|
|
Skin and subcutaneous tissue disorders
Nail dystrophia
|
7.7%
2/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Nervous system disorders
Neuropathia
|
30.8%
8/26 • Number of events 8 • Adverse Events were collected over the study observation period which was 22 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.2%
5/26 • Number of events 18 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Obstipation
|
15.4%
4/26 • Number of events 7 • Adverse Events were collected over the study observation period which was 22 months
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia
|
11.5%
3/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Nervous system disorders
Vertigo
|
11.5%
3/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Stomatitis
|
23.1%
6/26 • Number of events 12 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Thoracical pain
|
7.7%
2/26 • Number of events 2 • Adverse Events were collected over the study observation period which was 22 months
|
|
Gastrointestinal disorders
Nausea
|
30.8%
8/26 • Number of events 14 • Adverse Events were collected over the study observation period which was 22 months
|
|
General disorders
Oedema leg
|
26.9%
7/26 • Number of events 11 • Adverse Events were collected over the study observation period which was 22 months
|
|
Metabolism and nutrition disorders
Exsikkosis
|
7.7%
2/26 • Number of events 3 • Adverse Events were collected over the study observation period which was 22 months
|
Additional Information
Prof. Dr. med. Peter Hohenberger
Universität Heidelberg/Universitätsmedizin Mannheim
Phone: +49 0621 383 2609
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place