Trial Outcomes & Findings for Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer (NCT NCT02751827)

NCT ID: NCT02751827

Last Updated: 2025-08-24

Results Overview

Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0).

• Recruitment status: COMPLETED
• Target enrollment: 312 participants
• Primary outcome timeframe: During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.
• Results posted on: 2025-08-24

Participant Flow

Participant milestones

Measure	Prospective Cohort Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
Overall Study STARTED	41	171	100
Overall Study COMPLETED	41	171	99
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Prospective Cohort Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
Overall Study Only patient treated by TKI without anti-angiogenic action. He was excluded due to selection bias.	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prospective Cohort n=41 Participants Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A n=171 Participants Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B n=99 Participants Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Total n=311 Participants Total of all reporting groups
Age, Continuous	79 years n=41 Participants	74 years n=171 Participants	76 years n=99 Participants	75 years n=311 Participants
Sex: Female, Male Female	16 Participants n=41 Participants	98 Participants n=171 Participants	36 Participants n=99 Participants	150 Participants n=311 Participants
Sex: Female, Male Male	25 Participants n=41 Participants	73 Participants n=171 Participants	63 Participants n=99 Participants	161 Participants n=311 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	41 Participants n=41 Participants	171 Participants n=171 Participants	99 Participants n=99 Participants	311 Participants n=311 Participants

PRIMARY outcome

Timeframe: During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.

Population: Eligible and assessable population : All eligible patients who have received at least one TKI administration were included in analysis.

Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation.

All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0).

Outcome measures

Measure	Prospective Cohort n=41 Participants Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A n=171 Participants Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B n=99 Participants Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
Rate of Severe Toxicity	14 Participants	75 Participants	43 Participants

Adverse Events

Prospective Cohort

Serious events: 14 serious events

Other events: 36 other events

Deaths: 21 deaths

Retrospective Cohort A

Serious events: 75 serious events

Other events: 131 other events

Deaths: 62 deaths

Retrospective Cohort B

Serious events: 43 serious events

Other events: 76 other events

Deaths: 46 deaths

Serious adverse events

Measure	Prospective Cohort n=41 participants at risk Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A n=171 participants at risk Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B n=99 participants at risk Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
Blood and lymphatic system disorders Anemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Blood and lymphatic system disorders Macrophage activation syndrome	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Endocrine disorders Hypothyroidism	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Endocrine disorders Diabetes	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Eye disorders Blurred vision	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Abdominal pain	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Anal ulcer	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Colonic perforation	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.3% 9/171 • Number of events 9 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.1% 5/99 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Mucositis oral	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	6.1% 6/99 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Nausea	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Periodontal disease	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.0% 3/99 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Digestive problems	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Edema limbs	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Fatigue	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	15.2% 26/171 • Number of events 26 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	17.2% 17/99 • Number of events 18 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Localized edema	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Malaise	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Deterioration of general condition	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Hepatobiliary disorders Cholestasis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Bronchial infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Cranial nerve infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Kidney infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Lung infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Mucosal infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Paronychia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Sepsis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Urinary tract infection	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Alanine aminotransferase increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Alkaline phosphatase increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Blood bilirubin increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations GGT increased	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Neutrophil count decreased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Weight loss	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Anorexia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	8.8% 15/171 • Number of events 15 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.1% 5/99 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor bleeding	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Dysgeusia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Headache	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Hypersomnia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Intracranial hemorrhage	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Ischemia cerebrovascular	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Psychiatric disorders Mood disorders	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Hematuria	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Proteinuria	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.1% 7/171 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.0% 4/99 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Haemorrhage	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Dermal toxicity	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Skin rash	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Pruritic rash	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Hypertension	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.1% 5/99 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Hypotension	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.

Other adverse events

Measure	Prospective Cohort n=41 participants at risk Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort A n=171 participants at risk Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).	Retrospective Cohort B n=99 participants at risk Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).
Blood and lymphatic system disorders Anemia	14.6% 6/41 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	9.4% 16/171 • Number of events 16 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	11.1% 11/99 • Number of events 11 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Blood and lymphatic system disorders Thrombopenia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.0% 4/99 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Cardiac disorders Ventricular tachycardia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Ear and labyrinth disorders Tinnitus	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Ear and labyrinth disorders Vertigo	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Endocrine disorders Hypothyroidism	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	11.1% 11/99 • Number of events 11 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Eye disorders Conjunctivitis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Eye disorders Watering eyes	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Abdominal pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Ascites	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Bloating	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Constipation	9.8% 4/41 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Diarrhea	39.0% 16/41 • Number of events 18 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	18.7% 32/171 • Number of events 32 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	30.3% 30/99 • Number of events 30 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Dry mouth	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Gastritis	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.0% 4/99 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Gastrointestinal pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Mucositis oral	14.6% 6/41 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	12.3% 21/171 • Number of events 21 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	15.2% 15/99 • Number of events 15 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Nausea	19.5% 8/41 • Number of events 8 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	8.1% 8/99 • Number of events 8 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Small intestinal obstruction	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Vomiting	12.2% 5/41 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.7% 8/171 • Number of events 8 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Gastrointestinal disorders Sphincter disorders	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Edema limbs	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.8% 10/171 • Number of events 10 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Fatigue	65.9% 27/41 • Number of events 27 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	24.6% 42/171 • Number of events 42 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	56.6% 56/99 • Number of events 56 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Fever	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Gait disturbance	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
General disorders Altered general condition	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Hepatobiliary disorders Hepatic cytolysis	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Bronchial infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Lung infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Mucosal infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Sepsis	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Skin infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Tooth infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Urinary tract infection	7.3% 3/41 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Infections and infestations Staphylococcal infection	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Injury, poisoning and procedural complications Dermatitis radiation	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Alanine aminotransferase increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	9.4% 16/171 • Number of events 16 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Alkaline phosphatase increased	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	7.6% 13/171 • Number of events 13 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Blood bilirubin increased	4.9% 2/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.8% 3/171 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Cholesterol high	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	8.8% 15/171 • Number of events 15 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Creatinine increased	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.9% 5/171 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Electrocardiogram QT corrected interval prolonged	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Neutrophil count decreased	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.0% 3/99 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Platelet count decreased	17.1% 7/41 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.7% 8/171 • Number of events 8 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	10.1% 10/99 • Number of events 10 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Investigations Weight loss	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Anorexia	39.0% 16/41 • Number of events 17 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	11.1% 19/171 • Number of events 19 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	25.3% 25/99 • Number of events 25 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	9.4% 16/171 • Number of events 16 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Hypocalcemia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Metabolism and nutrition disorders Severe undernutrition	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	6.1% 6/99 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.9% 5/171 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Bone pain	4.9% 2/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.1% 7/171 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Myalgia	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Musculoskeletal and connective tissue disorders Cramps	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Dysgeusia	22.0% 9/41 • Number of events 10 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.3% 9/171 • Number of events 9 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.0% 3/99 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Headache	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Memory impairment	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Neuralgia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Paresthesia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.0% 3/99 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Agueusia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Nervous system disorders Hypoesthesia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Psychiatric disorders Insomnia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Psychiatric disorders Vigilance disorders	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Hematuria	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Renal and urinary disorders Urinary tract pain	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.8% 4/41 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	7.0% 12/171 • Number of events 12 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.0% 4/99 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.3% 3/41 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	5.3% 9/171 • Number of events 9 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.0% 3/99 • Number of events 3 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	6.1% 6/99 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Alopecia	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Dry skin	9.8% 4/41 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.1% 7/171 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	14.6% 6/41 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.9% 5/171 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	17.2% 17/99 • Number of events 17 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.3% 4/171 • Number of events 4 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	3.5% 6/171 • Number of events 6 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Rash acneiform	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	15.2% 26/171 • Number of events 26 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.9% 2/41 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.2% 2/171 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.0% 2/99 • Number of events 2 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Skin ulceration	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Erythematous lesion	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Skin rash	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.1% 7/171 • Number of events 7 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Cracks	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.58% 1/171 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Skin and subcutaneous tissue disorders Cutaneous hemorrhage	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Hypertension	12.2% 5/41 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	4.7% 8/171 • Number of events 8 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	15.2% 15/99 • Number of events 15 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Hypotension	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Superficial thrombophlebitis	2.4% 1/41 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/171 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	0.00% 0/99 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.
Vascular disorders Thromboembolic event	0.00% 0/41 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	2.9% 5/171 • Number of events 5 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.	1.0% 1/99 • Number of events 1 • During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment.

Additional Information

Pr Simone Mathoulin-Pelissier

Institut Bergonié

Phone: 0556333333

Email: S.Mathoulin@bordeaux.unicancer.fr

Results disclosure agreements

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