Trial Outcomes & Findings for Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary (NCT NCT00873119)
NCT ID: NCT00873119
Last Updated: 2015-07-28
Results Overview
Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study
Results posted on
2015-07-28
Participant Flow
Participant milestones
| Measure |
Arm A - BelCaP
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
|
Overall Study
COMPLETED
|
0
|
19
|
|
Overall Study
NOT COMPLETED
|
44
|
26
|
Reasons for withdrawal
| Measure |
Arm A - BelCaP
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Overall Study
Patient request
|
4
|
2
|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
Progressive disease
|
26
|
18
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Other
|
2
|
5
|
|
Overall Study
Not treated
|
2
|
0
|
Baseline Characteristics
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary
Baseline characteristics by cohort
| Measure |
Arm A - BelCaP
n=44 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=45 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
Total
n=89 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
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy
Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).
Outcome measures
| Measure |
Arm A - BelCaP
n=39 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=38 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Progression Free Survival
|
5.4 months
Interval 3.0 to 6.0
|
5.3 months
Interval 2.8 to 6.7
|
SECONDARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.
The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)
Outcome measures
| Measure |
Arm A - BelCaP
n=42 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=44 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Best Overall Response
|
43.2 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.
Time from the date of randomization to the date of death
Outcome measures
| Measure |
Arm A - BelCaP
n=34 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=37 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
11.5 months
Interval 6.9 to 18.0
|
9.1 months
Interval 6.6 to 11.0
|
SECONDARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Patients with overall best response being either complete response or partial response.
For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met
Outcome measures
| Measure |
Arm A - BelCaP
n=19 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=10 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Time to Response
|
3.2 months
Interval 0.0 to 19.1
|
NA months
Interval 0.0 to
Median missing due to sparse data
|
SECONDARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication
Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD (\[Progressive Disease\]) or death was documented
Outcome measures
| Measure |
Arm A - BelCaP
n=19 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=10 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Duration of Response
|
4.6 months
Interval 3.3 to 8.3
|
6.5 months
Interval 2.9 to 24.2
|
SECONDARY outcome
Timeframe: Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of studyPopulation: Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.
Time from the date of randomization to the time of disease progression
Outcome measures
| Measure |
Arm A - BelCaP
n=31 Participants
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=30 Participants
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Time to Progression (TTP)
|
5.7 months
Interval 4.5 to 7.2
|
5.6 months
Interval 2.8 to 7.5
|
Adverse Events
Arm A - BelCaP
Serious events: 22 serious events
Other events: 42 other events
Deaths: 0 deaths
Arm B - CaP
Serious events: 10 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - BelCaP
n=42 participants at risk
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=44 participants at risk
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Eye disorders
Visual impairment
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Immune system disorders
Drug hypersensitivity
|
4.8%
2/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Immune system disorders
Hypersensitivity
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Cystitis
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Device related infection
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Retroperitoneal abscess
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Haemoglobin decreased
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Transaminases increased
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Psychiatric disorders
Panic attack
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Arterial occlusive disease
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Venous stenosis
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Pneunomia
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
Other adverse events
| Measure |
Arm A - BelCaP
n=42 participants at risk
Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
|
Arm B - CaP
n=44 participants at risk
Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
85.7%
36/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
59.1%
26/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
57.1%
24/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
38.6%
17/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Vomiting
|
61.9%
26/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
29.5%
13/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Constipation
|
45.2%
19/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
40.9%
18/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
8/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
25.0%
11/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Fatigue
|
64.3%
27/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
65.9%
29/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Oedema peripheral
|
23.8%
10/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
22.7%
10/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Asthenia
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Pyrexia
|
16.7%
7/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Chest pain
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Mucosal inflammation
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Chills
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
General disorders
Pain
|
4.8%
2/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.4%
22/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
61.4%
27/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.8%
10/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
13.6%
6/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
7/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
31.8%
14/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
9/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
22.7%
10/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
31.8%
14/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.2%
11/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
13.6%
6/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
2/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
35.7%
15/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
18.2%
8/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
7/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
25.0%
11/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
15.9%
7/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Dysgeusia
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Headache
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
13.6%
6/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Nervous system disorders
Paraesthesia
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.6%
20/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
36.4%
16/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
23.8%
10/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
18.2%
8/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Anaemia
|
40.5%
17/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
15.9%
7/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.0%
13/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
22.7%
10/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
14/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
18.2%
8/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
10/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
20.5%
9/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
9/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
22.7%
10/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Urinary tract infection
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Infections and infestations
Oral candidiasis
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Flushing
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
15.9%
7/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Hypotension
|
11.9%
5/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Phlebitis
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
2.3%
1/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Vascular disorders
Hot flush
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Weight decreased
|
9.5%
4/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Platelet count decreased
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
9.1%
4/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Haemoglobin decreased
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
4.5%
2/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Increased haemoglobin
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Investigations
Neutrophil count decreased
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
0.00%
0/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Psychiatric disorders
Insomnia
|
16.7%
7/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
20.5%
9/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Psychiatric disorders
Anxiety
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
6/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
11.4%
5/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Renal and urinary disorders
Dysuria
|
7.1%
3/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/42
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
6.8%
3/44
Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60