Trial Outcomes & Findings for A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas (NCT NCT00274651)

NCT ID: NCT00274651

Last Updated: 2015-07-28

Results Overview

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: throughout the study, or for a maximum of 2 years
• Results posted on: 2015-07-28

Participant Flow

Participant milestones

Measure	Arm A (CTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days	Arm B (PTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days
Overall Study STARTED	29	24
Overall Study COMPLETED	1	4
Overall Study NOT COMPLETED	28	20

Reasons for withdrawal

Measure	Arm A (CTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days	Arm B (PTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days
Overall Study Adverse Event	6	3
Overall Study Lack of Efficacy	13	6
Overall Study Death	1	3
Overall Study Withdrawal by Subject	0	1
Overall Study Physician Decision	8	7

Baseline Characteristics

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Baseline characteristics by cohort

Measure	CTCL (ITT Population) n=29 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	PTCL (ITT Population) n=24 Participants PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Total n=53 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 13.4 • n=5 Participants	58.8 years STANDARD_DEVIATION 15.9 • n=7 Participants	61.7 years STANDARD_DEVIATION 14.7 • n=5 Participants
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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	17 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Israel	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Thailand	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented

Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.

Outcome measures

Measure	Arm A (CTCL, ITT Population) n=24 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))	25 percentage of patients with OR	—

SECONDARY outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.

Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.

Outcome measures

Measure	Arm A (CTCL, ITT Population) n=23 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) n=14 Participants PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Time to Progression	43 Days Interval 15.0 to 304.0	82 Days Interval 9.0 to 890.0

SECONDARY outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.

Time to response was defined as the interval between the first date of treatment and the first notation of response.

Outcome measures

Measure	Arm A (CTCL, ITT Population) n=4 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) n=6 Participants PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Time to Response	40 Days Interval 15.0 to 176.0	100 Days Interval 9.0 to 431.0

SECONDARY outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days

Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.

Outcome measures

Measure	Arm A (CTCL, ITT Population) n=2 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) n=4 Participants PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Duration of Response	83 Days Interval 56.0 to 129.0	109 Days Interval 7.0 to 460.0

POST_HOC outcome

Timeframe: throughout the study, or for a maximum of 2 years

Population: At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

Outcome measures

Measure	Arm A (CTCL, ITT Population) n=29 Participants CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)	4 participants	—

Adverse Events

Arm A (CTCL, ITT Population)

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

Arm B (PTCL, ITT Population)

Serious events: 8 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (CTCL, ITT Population) n=29 participants at risk CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) n=24 participants at risk PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Disease progression	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Staphylococcal skin infection	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Gait disturbance	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Oedema peripheral	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Nervous system disorders Apraxia	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Vascular disorders Jugular vein thrombosis	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Implant site abscess	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Sepsis	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Cardiac disorders Ventricular fibrillation	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Pyrexia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Pneumonia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Ileus paralytic	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Catheter related infection	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Upper respiratory tract infection	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.

Other adverse events

Measure	Arm A (CTCL, ITT Population) n=29 participants at risk CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV	Arm B (PTCL, ITT Population) n=24 participants at risk PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
General disorders Fatigue	20.7% 6/29 • Number of events 11 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	33.3% 8/24 • Number of events 11 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Pyrexia	17.2% 5/29 • Number of events 9 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	25.0% 6/24 • Number of events 16 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Infusion site pain	20.7% 6/29 • Number of events 6 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Oedema peripheral	20.7% 6/29 • Number of events 7 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Injection site reaction	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	20.8% 5/24 • Number of events 9 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Asthenia	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Chest pain	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Chills	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Disease progression	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Gait disturbance	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Oedema	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Nausea	58.6% 17/29 • Number of events 29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	66.7% 16/24 • Number of events 32 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Constipation	17.2% 5/29 • Number of events 5 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	37.5% 9/24 • Number of events 10 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Vomiting	27.6% 8/29 • Number of events 14 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	25.0% 6/24 • Number of events 19 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Diarrhoea	13.8% 4/29 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	20.8% 5/24 • Number of events 10 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Dyspepsia	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Nervous system disorders Dizziness	20.7% 6/29 • Number of events 7 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	20.8% 5/24 • Number of events 8 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Nervous system disorders Headache	20.7% 6/29 • Number of events 6 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Nervous system disorders Dysgeusia	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Nervous system disorders Hypoparaesthesia	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Anorexia	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	20.8% 5/24 • Number of events 5 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Hypokalaemia	10.3% 3/29 • Number of events 5 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	16.7% 4/24 • Number of events 9 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	16.7% 4/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Hypoalbuminaemia	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Skin and subcutaneous tissue disorders Pruritus	24.1% 7/29 • Number of events 8 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Skin and subcutaneous tissue disorders Rash	13.8% 4/29 • Number of events 5 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Skin and subcutaneous tissue disorders Skin exfoliation	13.8% 4/29 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Alanine aminotransferase increased	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Aspartate aminotransferase increased	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Blood alkaline phosphatase increased	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Blood lactate dehydrogenase increased	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Upper respiratory tract infection	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Cellulitis	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	17.2% 5/29 • Number of events 6 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	20.8% 5/24 • Number of events 5 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Myalgia	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Muscular weakness	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Back pain	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.8% 4/29 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Respiratory, thoracic and mediastinal disorders Cough	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Vascular disorders Flushing	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	16.7% 4/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Vascular disorders Phlebitis	10.3% 3/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Cardiac disorders Tachycardia	3.4% 1/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 6 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Blood and lymphatic system disorders Eosinophilia	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Blood and lymphatic system disorders Lymphadenopathy	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	12.5% 3/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Psychiatric disorders Confusional state	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Psychiatric disorders Insomnia	3.4% 1/29 • Number of events 1 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 4 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
General disorders Mucosal inflammation	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Abdominal distension	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Gastrointestinal disorders Stomatitis	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Blood creatinine increased	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Blood magnesium decreased	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Blood uric acid increased	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Investigations Body temperature increased	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Herpes simplex	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Pneumonia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Sepsis	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Skin infection	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Infections and infestations Tinea pedis	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Muscle spams	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	4.2% 1/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Musculoskeletal and connective tissue disorders Neck pain	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Vascular disorders Hypotension	6.9% 2/29 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Blood and lymphatic system disorders Anaemia	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Ear and labyrinth disorders Vertigo	6.9% 2/29 • Number of events 3 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	0.00% 0/24 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.
Immune system disorders Hypersensitivity	0.00% 0/29 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.	8.3% 2/24 • Number of events 2 • Throughout study, up to 4 weeks after last drug administration Follow-up of the AE (adverse event) was required during the study and after completion, withdrawal or discontinuation of the study if the event was still ongoing. The Investigator was to continuously monitor patients with AEs until the event had returned to baseline or ≤ Grade 1 or until the patient started another type of antineoplastic therapy.

Additional Information

PRS Admnistrator Gunilla Emanuelson

Topotarget A/S

Phone: +45 39 17 83 92

Email: enquiries@topotarget.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60