Trial Outcomes & Findings for Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study (NCT NCT03517137)

NCT ID: NCT03517137

Last Updated: 2025-08-11

Results Overview

Modified PFS (mPFS) is defined as the time interval between the date of treatment start and the date of the first of: * Progressive disease (PD) * Start of new treatment for Classical Hodgkin Lymphoma (cHL) when not in Complete Response at the end of protocol treatment; in this case, the date of mPFS is the date of the FDG-PET/CT scan at the end of protocol treatment. Switching therapy prior to end of protocol treatment for reasons other than Progressive Disease is not considered an event for mPFS. "End of protocol treatment" refers to completion of the planned protocol treatment with no more than 1 missed cycle, including radiotherapy on PET positive lesions if administered * Death due to any cause

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: 2 years from the date of treatment start
• Results posted on: 2025-08-11

Participant Flow

Participant milestones

Measure	Treatment Patients will receive 1 cycle of BrAVD followed by a PET/CT scan (PET1). Further treatment will be based on the PET1 results scored according to the Deauville 5-point score (DS) as follows: 1. If PET1-negative (DS: 1-3): patients will receive an additional 5 cycles of BrAVD 2. If PET1-positive (DS: 4-5): patients will switch treatment and receive 6 cycles of BrECADD Radiotherapy will be applied only to patients with residual PET positivity (Deauville 4 or 5) at the end of chemotherapy. Only sites of residual PET positive disease will be irradiated.
Overall Study STARTED	150
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Treatment Patients will receive 1 cycle of BrAVD followed by a PET/CT scan (PET1). Further treatment will be based on the PET1 results scored according to the Deauville 5-point score (DS) as follows: 1. If PET1-negative (DS: 1-3): patients will receive an additional 5 cycles of BrAVD 2. If PET1-positive (DS: 4-5): patients will switch treatment and receive 6 cycles of BrECADD Radiotherapy will be applied only to patients with residual PET positivity (Deauville 4 or 5) at the end of chemotherapy. Only sites of residual PET positive disease will be irradiated.
Overall Study Lack of Efficacy	1
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study Poor therapy tolerance, ineligibility, AE, error in treatment administration	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment n=150 Participants Patients will receive 1 cycle of BrAVD followed by a PET/CT scan (PET1). Further treatment will be based on the PET1 results scored according to the Deauville 5-point score (DS) as follows: 1. If PET1-negative (DS: 1-3): patients will receive an additional 5 cycles of BrAVD 2. If PET1-positive (DS: 4-5): patients will switch treatment and receive 6 cycles of BrECADD Radiotherapy will be applied only to patients with residual PET positivity (Deauville 4 or 5) at the end of chemotherapy. Only sites of residual PET positive disease will be irradiated.
Age, Continuous	32 years n=150 Participants
Sex: Female, Male Female	69 Participants n=150 Participants
Sex: Female, Male Male	81 Participants n=150 Participants
Region of Enrollment Netherlands	42 participants n=150 Participants
Region of Enrollment Belgium	17 participants n=150 Participants
Region of Enrollment Denmark	21 participants n=150 Participants
Region of Enrollment Poland	2 participants n=150 Participants
Region of Enrollment Slovakia	16 participants n=150 Participants
Region of Enrollment Portugal	17 participants n=150 Participants
Region of Enrollment Spain	35 participants n=150 Participants
WHO performance status 0	117 Participants n=150 Participants
WHO performance status 1	29 Participants n=150 Participants
WHO performance status 2	4 Participants n=150 Participants
Histology type Nodular sclerosis	106 Participants n=150 Participants
Histology type Mixed cellularity	21 Participants n=150 Participants
Histology type Lymphocyte depleted	1 Participants n=150 Participants
Histology type Lymphocyte rich	1 Participants n=150 Participants
Histology type Not otherwise specified	21 Participants n=150 Participants
Ann Arbor clinical stage IIB	22 Participants n=150 Participants
Ann Arbor clinical stage IIIA	16 Participants n=150 Participants
Ann Arbor clinical stage IIIB	23 Participants n=150 Participants
Ann Arbor clinical stage IVA	34 Participants n=150 Participants
Ann Arbor clinical stage IVB	55 Participants n=150 Participants
Any relevant non-malignant medical condition No	44 Participants n=150 Participants
Any relevant non-malignant medical condition Yes	106 Participants n=150 Participants
Any history of diabetes mellitus No	148 Participants n=150 Participants
Any history of diabetes mellitus Yes	2 Participants n=150 Participants
Any history blood hypertension No	136 Participants n=150 Participants
Any history blood hypertension Yes	14 Participants n=150 Participants
Any malignant medical condition No	149 Participants n=150 Participants
Any malignant medical condition Yes	1 Participants n=150 Participants

PRIMARY outcome

Timeframe: 2 years from the date of treatment start

Population: All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review.

Modified PFS (mPFS) is defined as the time interval between the date of treatment start and the date of the first of:

• Progressive disease (PD)
• Start of new treatment for Classical Hodgkin Lymphoma (cHL) when not in Complete Response at the end of protocol treatment; in this case, the date of mPFS is the date of the FDG-PET/CT scan at the end of protocol treatment. Switching therapy prior to end of protocol treatment for reasons other than Progressive Disease is not considered an event for mPFS. "End of protocol treatment" refers to completion of the planned protocol treatment with no more than 1 missed cycle, including radiotherapy on PET positive lesions if administered
• Death due to any cause

Outcome measures

Measure	Evaluable Population n=145 Participants All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review.
Modified Progression-free Survival (mPFS) Rate at 2 Years	89.5 Percent probability Interval 85.7 to 92.4

SECONDARY outcome

Timeframe: At day 22 to 23 from start of treatment (day 1 = date of start of treatment)

It will be assessed how many patients have a negative FDG-PET image when taken at the end of their first cycle of BrAVD. The BrAVD cycle lasts 4 weeks.

Outcome measures

Measure	Evaluable Population n=150 Participants All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review.
Proportion of Patients With a Negative FDG-PET Negative	90 Participants
Proportion of Patients With a Negative FDG-PET Positive	60 Participants

SECONDARY outcome

Timeframe: 2 years from the date of treatment start

Progression-free survival

Outcome measures

Measure	Evaluable Population n=145 Participants All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review.
Progression-free Survival (PFS) Rate at 2 Years	89.5 Percent probability Interval 83.3 to 93.6

SECONDARY outcome

Timeframe: 2 years from the date of treatment start

Overall survival

Outcome measures

Measure	Evaluable Population n=145 Participants All registered and eligible patients, who started the allocated treatment according to the result of the FDG-PET/CT after 1 cycle of BrAVD, as assessed by central review.
Overall Survival Rate at 2 Years	100 Percent probability

Adverse Events

Treatment

Serious events: 45 serious events

Other events: 149 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=150 participants at risk Brentuximab Vedotin: For PET positive patients: IV infusion over a period of 30 minutes at 1.8 mg/kg on day 1, every 3 weeks (6 cycles); For PET negative patients: IV infusion over a period of 30 minutes at 1.2 mg/kg on day 1 and 15, every 4 weeks (5 cycles) Adriamycin: For PET positive patients: IV infusion over a period of 15 minutes at 40 mg/m² on day 2, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: IV infusion over a period of 15 minutes at 25 mg/m² on day 1 and 15, every 4 weeks (5 cycles) Vinblastine: For PET negative patients: IV infusion over a period of 15 minutes at 6mg/m² on day 1 and 15, every 4 weeks (5 cycles) Dacarbazine: For PET positive patients: IV infusion over a period of 60 minutes at 250 mg/m² on day 3 and 4, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: IV infusion over a period of 60 minutes at 375 mg/m² on day 1 and 15, every 4 weeks (5 cycles) Etoposide: For PET positive patients: administered as an IV infusion over a period of 60 minutes at 150 mg/m² on day 2,3 and 4, every 3 weeks (6 cycles) Cyclophosphamide: For PET positive patients: administered as an IV infusion over a period of 30 minutes at 1250 mg/m² on day 2, every 3 weeks (6 cycles) Radiation Therapy: Patients with residual lymphoma mass(es) showing metabolic activity of Deauville score 4 or 5 after completion of chemotherapy will be offered consolidation radiotherapy.
Blood and lymphatic system disorders ANAEMIA	2.7% 4/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	6.7% 10/150 • Number of events 16 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Blood and lymphatic system disorders NEUTROPENIA	2.7% 4/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders CARDIAC TAMPONADE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders PERICARDIAL EFFUSION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders PRINZMETAL ANGINA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ABDOMINAL PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders CONSTIPATION	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ILEUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders INTESTINAL PSEUDO-OBSTRUCTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders NAUSEA	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders NEUTROPENIC COLITIS	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders PANCREATITIS ACUTE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders STOMATITIS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders VOMITING	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders MUCOSAL INFLAMMATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders PYREXIA	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Hepatobiliary disorders HEPATIC HAEMORRHAGE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations COVID-19	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations DEVICE RELATED INFECTION	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ENTEROCOLITIS INFECTIOUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations GASTROENTERITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations GASTROENTERITIS CLOSTRIDIAL	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations GASTROINTESTINAL INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTION	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTIOUS PLEURAL EFFUSION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations MENINGITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ORAL CANDIDIASIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ORAL INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PNEUMONIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PNEUMONIA PSEUDOMONAL	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SEPSIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SEPTIC SHOCK	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations STAPHYLOCOCCAL INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations THROMBOPHLEBITIS SEPTIC	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations TOOTH ABSCESS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations TOOTH INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations TUBO-OVARIAN ABSCESS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations INFLUENZA A VIRUS TEST POSITIVE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations PLATELET COUNT DECREASED	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders HYPONATRAEMIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders BACK PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders AUTONOMIC NEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders DEMYELINATING POLYNEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders NEUROPATHY PERIPHERAL	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders SUICIDE ATTEMPT	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders HIDRADENITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).

Other adverse events

Measure	Treatment n=150 participants at risk Brentuximab Vedotin: For PET positive patients: IV infusion over a period of 30 minutes at 1.8 mg/kg on day 1, every 3 weeks (6 cycles); For PET negative patients: IV infusion over a period of 30 minutes at 1.2 mg/kg on day 1 and 15, every 4 weeks (5 cycles) Adriamycin: For PET positive patients: IV infusion over a period of 15 minutes at 40 mg/m² on day 2, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: IV infusion over a period of 15 minutes at 25 mg/m² on day 1 and 15, every 4 weeks (5 cycles) Vinblastine: For PET negative patients: IV infusion over a period of 15 minutes at 6mg/m² on day 1 and 15, every 4 weeks (5 cycles) Dacarbazine: For PET positive patients: IV infusion over a period of 60 minutes at 250 mg/m² on day 3 and 4, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: IV infusion over a period of 60 minutes at 375 mg/m² on day 1 and 15, every 4 weeks (5 cycles) Etoposide: For PET positive patients: administered as an IV infusion over a period of 60 minutes at 150 mg/m² on day 2,3 and 4, every 3 weeks (6 cycles) Cyclophosphamide: For PET positive patients: administered as an IV infusion over a period of 30 minutes at 1250 mg/m² on day 2, every 3 weeks (6 cycles) Radiation Therapy: Patients with residual lymphoma mass(es) showing metabolic activity of Deauville score 4 or 5 after completion of chemotherapy will be offered consolidation radiotherapy.
Blood and lymphatic system disorders ANEMIA	26.7% 40/150 • Number of events 147 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	9.3% 14/150 • Number of events 23 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Blood and lymphatic system disorders LYMPH NODE PAIN	2.0% 3/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders CHEST PAIN - CARDIAC	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders PERICARDIAL EFFUSION	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Cardiac disorders SINUS TACHYCARDIA	4.7% 7/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Ear and labyrinth disorders EAR PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Ear and labyrinth disorders HEARING IMPAIRED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Ear and labyrinth disorders MIDDLE EAR INFLAMMATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Ear and labyrinth disorders TINNITUS	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Ear and labyrinth disorders VESTIBULAR DISORDER	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Eye disorders BLEPHARITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Eye disorders DRY EYE	5.3% 8/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ABDOMINAL PAIN	19.3% 29/150 • Number of events 43 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ANAL FISSURE	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ANAL PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders BLOATING	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders BURNING FEELING STOMACH	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders COLONIC OBSTRUCTION	0.67% 1/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders CONSTIPATION	37.3% 56/150 • Number of events 82 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders DIARRHEA	18.7% 28/150 • Number of events 35 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders DRY MOUTH	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders DYSPEPSIA	4.0% 6/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ENTEROCOLITIS	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ESOPHAGITIS	0.67% 1/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders FLATULENCE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTRITIS	2.0% 3/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTROENTERITIS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - BLOOD IN STOOL	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - HEARTBURN	0.67% 1/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders GLOSSITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders HEARTBURN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders HEMORRHOIDAL HEMORRHAGE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders HEMORRHOIDS	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ILEUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders MUCOSITIS (OF MOUTH, ESOPHAGUS, STOMACH AND DUODENUM)	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders MUCOSITIS OF MOUTH, ESOPHAGUS, STOMACH AND DUODENDUM	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders MUCOSITIS ORAL	16.0% 24/150 • Number of events 39 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders NAUSEA	42.7% 64/150 • Number of events 126 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders NEUTROPENIC COLITIS	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders OBSTIPATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ORAL PAIN	2.7% 4/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders OTHER GASTROINTESTINAL DISORDERS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders PANCREATITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders PERIODONTAL DISEASE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders PYROSIS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders RECTAL HEMORRHAGE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders REFLUX	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders ROUGH GUM	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders SENSITIVE MOUTH	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders STOMACH PAIN	4.7% 7/150 • Number of events 12 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders TOOTHACHE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Gastrointestinal disorders VOMITING	20.7% 31/150 • Number of events 49 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders EDEMA LIMBS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders FATIGUE	35.3% 53/150 • Number of events 88 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders FEVER	16.0% 24/150 • Number of events 45 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders FLU LIKE SYMPTOMS	3.3% 5/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders GENERAL DISORDERS - WARM-COLD FEELING	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders GENERALIZED EDEMA	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders INFUSION RELATED REACTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders IRRITABILITY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders LOCALIZED EDEMA	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders MALAISE	6.0% 9/150 • Number of events 12 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders NON-CARDIAC CHEST PAIN	4.7% 7/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
General disorders PAIN	4.0% 6/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Hepatobiliary disorders HEPATIC HEMORRHAGE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Hepatobiliary disorders HEPATIC TOXICITY	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Hepatobiliary disorders HEPATITIS VIRAL	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Immune system disorders ALLERGIC REACTION	2.0% 3/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Immune system disorders HYPOGAMMAGLOBULINEMIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Immune system disorders THYMUS HYPERPLASIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ABDOMINAL INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations BACTEREMIA	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations CATHETER RELATED INFECTION	2.0% 3/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations COVID 19 INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations COVID-19	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations COVID-19 INFECTION	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations COVID19 INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ENTEROCOLITIS INFECTIOUS	2.7% 4/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations EYE INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations FOLLICULITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations HERPES SIMPLEX REACTIVATION	4.0% 6/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTION	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTION, STAPHYLOCOCCUS HAEMOLYTICUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTION, UNKNOWN FOCUS	1.3% 2/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations INFECTIONS AND INFESTATIONS, OTHER (COVID-19)	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations LIP INFECTION	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations LUNG INFECTION	4.7% 7/150 • Number of events 11 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations MENINGITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations MOUTH INFECTION	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations MUCOSAL INFECTION	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations OTITIS MEDIA	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations OVARIAN INFECTION	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PAPULOPUSTULAR RASH	1.3% 2/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PHARYNGITIS	4.0% 6/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PHLEBITIS INFECTIVE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations PNEUMOCYSTIS JIROVECI PNEUMONIA INFECTION	0.67% 1/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations RHINITIS INFECTIVE	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SEPSIS	1.3% 2/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SEPTIC THROMBOPHLEBITIS	0.67% 1/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SHINGLES	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SINUSITIS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SKIN INFECTION	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SMALL INTESTINE INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SUSPECTED PNEUMOCYSTIS JIROVECI PNEUMONIA	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations SUSPICIOUS INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations THRUSH	4.0% 6/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations TONSILLITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations TOOTH INFECTION	4.7% 7/150 • Number of events 9 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations UPPER RESPIRATORY INFECTION	4.7% 7/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION DUE TO INFLUENZA A	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations URINARY TRACT INFECTION	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations VAGINAL INFECTION	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations WOUND INFECTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Infections and infestations ZOSTER	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Injury, poisoning and procedural complications INFUSION RELATED REACTION	3.3% 5/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Injury, poisoning and procedural complications PAIN PICC KATHETER	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Injury, poisoning and procedural complications PAINFUL VEIN AFTER INFUSION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations ALANINE AMINOTRANSFERASE INCREASED	10.7% 16/150 • Number of events 22 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations ALKALINE PHOSPHATASE INCREASED	3.3% 5/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	6.0% 9/150 • Number of events 9 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations BLOOD BILIRUBIN INCREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations CARBON MONOXIDE DIFFUSING CAPACITY DECREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations EJECTION FRACTION DECREASED	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations FORCED EXPIRATORY VOLUME DECREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations GGT INCREASED	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations LYMPHOCYTE COUNT DECREASED	4.0% 6/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations NEUTROPHIL COUNT DECREASED	36.7% 55/150 • Number of events 149 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations PLATELET COUNT DECREASED	11.3% 17/150 • Number of events 85 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations TRANSAMINITIS	0.67% 1/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations WEIGHT GAIN	8.0% 12/150 • Number of events 23 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations WEIGHT LOSS	11.3% 17/150 • Number of events 32 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations WHITE BLOOD CELL DECREASED	12.0% 18/150 • Number of events 60 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations WHITE BLOOD CELL INCREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Investigations WHITE BLOOD CELLS INCREASED	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders ANOREXIA	10.7% 16/150 • Number of events 26 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders DIABETES MELLITUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders HYPERURICEMIA	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders HYPOKALEMIA	5.3% 8/150 • Number of events 12 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders HYPOMAGNESEMIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders HYPONATREMIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Metabolism and nutrition disorders TUMOR LYSIS SYNDROME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.7% 7/150 • Number of events 9 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders BACK PAIN	10.7% 16/150 • Number of events 22 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders BONE PAIN	18.0% 27/150 • Number of events 42 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders FATIGUE IN ARMS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders INFLAMMATION OF TENDONS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders MYALGIA	15.3% 23/150 • Number of events 34 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders NECK PAIN	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders OTHER, HEAVY ARMS AND LEGS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders PAIN BACK/HIPS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.3% 8/150 • Number of events 9 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders PAIN RIBS/HIP	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders PAIN, GROIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Musculoskeletal and connective tissue disorders STERNUM DISCOMFORT	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders ANOSMIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders CONCENTRATION IMPAIRMENT	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders DIZZINESS	7.3% 11/150 • Number of events 13 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders DYSGEUSIA	13.3% 20/150 • Number of events 28 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders DYSPHASIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders EXTRAPYRAMIDAL DISORDER	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders RESTLESSNESS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders HEADACHE	10.7% 16/150 • Number of events 25 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders MEMORY IMPAIRMENT	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PARESTHESIA	10.7% 16/150 • Number of events 18 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL AUTONOMIC NEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	20.0% 30/150 • Number of events 42 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	52.7% 79/150 • Number of events 149 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders SENSITIVE MOTOR SYNDROME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders SENSORY AND MOTOR POLYNEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders SYNCOPE	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders TRANSIENT ISCHEMIC ATTACKS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Nervous system disorders VEGETATIVE NEUROPATHY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders AGITATION	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders ANXIETY	4.0% 6/150 • Number of events 6 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders INSOMNIA	17.3% 26/150 • Number of events 31 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders IRRITABILITY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders PSYCHIATRIC DISORDERS - EMOTIONAL DISTRESS	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Psychiatric disorders SUICIDE ATTEMPT	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Renal and urinary disorders CYSTITIS NONINFECTIVE	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Renal and urinary disorders URINARY FREQUENCY	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Renal and urinary disorders URINARY RETENTION	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Renal and urinary disorders URINARY TRACT OBSTRUCTION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Renal and urinary disorders URINE DISCOLORATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders BREAST PAIN	2.0% 3/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders PELVIC PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders PREMATURE MENOPAUSE	2.0% 3/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders SCROTAL PAIN	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders TESTICULAR PAIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Reproductive system and breast disorders VAGINAL DISCHARGE	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders COUGH	6.7% 10/150 • Number of events 16 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders DYSPNEA	10.7% 16/150 • Number of events 20 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders EXTRINSIC ALLERGIC ALVEOLITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders HICCUPS	3.3% 5/150 • Number of events 7 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders HOARSENESS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PULMONARY EMPYEMA	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders PULMONARY TOXICITY WITH REDUCT OF CARB MONOX DIFFUSING CAPAC	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders RHINORRHEA	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Respiratory, thoracic and mediastinal disorders SORE THROAT	3.3% 5/150 • Number of events 5 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders ACNE	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders ALOPECIA	10.7% 16/150 • Number of events 22 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders BODY ODOR	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders CUTANEOUS ABSCESS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders DRY SKIN	5.3% 8/150 • Number of events 8 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders ECZEMA	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders ERYTHEMA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders EXANTHEM	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders HYPERHIDROSIS	7.3% 11/150 • Number of events 11 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders PAIN OF SKIN	0.67% 1/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders PRURITUS	7.3% 11/150 • Number of events 12 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders RASH ACNEIFORM	2.0% 3/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	7.3% 11/150 • Number of events 14 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders RIGHT AXILLARY HIDRADENITIS SUPPURATIVA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - EASILY GETS WOUNDS	0.67% 1/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - SENSITIVE SKIN	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - SKIN IRRITATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS- SKIN IRRITATION ANUS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders SWEET SYNDROME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Skin and subcutaneous tissue disorders URTICARIA	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders FLUSHING	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders HOT FLASHES	2.7% 4/150 • Number of events 4 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders HYPERTENSION	13.3% 20/150 • Number of events 53 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders HYPOTENSION	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders PHLEBITIS	1.3% 2/150 • Number of events 2 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders SUPERFICIAL THROMBOPHLEBITIS	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders SUPERIOR VENA CAVA SYNDROME	0.67% 1/150 • Number of events 1 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).
Vascular disorders THROMBOEMBOLIC EVENT	1.3% 2/150 • Number of events 3 • Each observed adverse event was to be reported as of 4 weeks within registration until 28 days after start of last cycle of chemotherapy. If radiotherapy given, assessment of adverse events should be done until 8 weeks after completion. Related adverse events should be assessed as of 3 months after the end of treatment until 5 years after end of treatment. All adverse events must be followed until resolution or stabilization. Survival status: assessed until 5 years after end of treatment. All AEs will be reported in Other section (Serious and non-Serious).

Additional Information

Catherine Fortpied

EORTC

Phone: +32 2 774 1681

Email: catherine.fortpied@eortc.org

Results disclosure agreements

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