Trial Outcomes & Findings for A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy (NCT NCT02743221)

Last Updated: 2024-08-20

Results Overview

The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

154 participants

Primary outcome timeframe

Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Results posted on

2024-08-20

Participant Flow

154 patients were randomized among whom one was deemed ineligible after randomization.

Participant milestones

Participant milestones
Measure	Trifluridine/Tipiracil + Bevacizumab Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Overall Study STARTED	77	77
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	56	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Trifluridine/Tipiracil + Bevacizumab Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Overall Study Progressive disease	29	38
Overall Study Adverse Event	17	14
Overall Study non medical reason	8	2
Overall Study Physician Decision	2	5
Overall Study Patient not eligible, not treated	0	1

Baseline Characteristics

A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=77 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Age, Continuous	69.8 years STANDARD_DEVIATION 10.2 • n=5 Participants	72.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	71.3 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	48 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized White	73 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Not collected	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Population: Full Analysis Set (FAS): all randomised patients who have taken at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Progression Free Survival (PFS)	9.2 months Interval 7.6 to 11.6	7.8 months Interval 5.5 to 10.2

SECONDARY outcome

Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Population: FAS

As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.

Outcome measures

Outcome measures
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Overall Response Rate (ORR)	26 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)

Population: Tumour Response population: patients with measurable disease at baseline and with at least one tumour evaluation while on treatment.

The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.

Outcome measures

Outcome measures
Measure	Trifluridine/Tipiracil + Bevacizumab n=74 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=73 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Duration of Response (DR)	7.9 months Interval 6.01 to 14.75	9.9 months Interval 8.41 to 10.02

SECONDARY outcome

Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Population: FAS

DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Disease Control Rate (DCR)	66 Participants	59 Participants

SECONDARY outcome

Timeframe: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

Population: FAS

The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.

Outcome measures

Outcome measures
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 Participants Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 Participants Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Overall Survival (OS)	18.0 months Interval 15.18 to 19.48	16.2 months Interval 13.07 to 17.67

Adverse Events

Trifluridine/Tipiracil + Bevacizumab

Serious events: 42 serious events

Other events: 75 other events

Deaths: 22 deaths

Capecitabine + Bevacizumab

Serious events: 44 serious events

Other events: 69 other events

Deaths: 33 deaths

Serious adverse events

Other adverse events

Additional Information

Dr Patrick Therasse

Institut de Recherches Internationales Servier (I.R.I.S.)

Phone: +33 1 55 72 43 47

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 participants at risk Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 participants at risk Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Blood and lymphatic system disorders Anaemia	3.9% 3/77 • Number of events 4 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Febrile neutropenia	3.9% 3/77 • Number of events 3 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	3.9% 3/76 • Number of events 3 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Haemorrhagic anaemia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Neutropenia	5.2% 4/77 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Acute coronary syndrome	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Atrial fibrillation	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Atrioventricular block complete	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Mitral valve incompetence	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Myocardial infarction	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Supraventricular tachycardia	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Ventricular tachycardia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Endocrine disorders Hypothyroidism	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Ascites	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Diarrhoea	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	6.6% 5/76 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Enterocutaneous fistula	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Gastrointestinal angiodysplasia haemorrhagic	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Haematemesis	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Ileus paralytic	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Intestinal obstruction	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Intestinal perforation	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Large intestine perforation	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Malignant bowel obstruction	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Nausea	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Pancreatitis	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Proctalgia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Small intestinal obstruction	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Umbilical hernia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Vomiting	2.6% 2/77 • Number of events 4 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
General disorders Death	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
General disorders General physical health deterioration	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
General disorders Mucosal dryness	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
General disorders Multiple organ dysfunction syndrome	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
General disorders Non-cardiac chest pain	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Hepatobiliary disorders Cholecystitis	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Hepatobiliary disorders Cholecystitis acute	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Hepatobiliary disorders Cholelithiasis	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Hepatobiliary disorders Hepatic failure	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Hepatobiliary disorders Hepatotoxicity	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Infections and infestations Abdominal abscess	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose

Other adverse events
Measure	Trifluridine/Tipiracil + Bevacizumab n=77 participants at risk Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Capecitabine + Bevacizumab n=76 participants at risk Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Blood and lymphatic system disorders Anaemia	28.6% 22/77 • Number of events 31 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	6.6% 5/76 • Number of events 7 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Anaemia of chronic disease	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Anaemia of malignant disease	6.5% 5/77 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Febrile neutropenia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Haemolytic anaemia	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Leukopenia	7.8% 6/77 • Number of events 9 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Neutropenia	51.9% 40/77 • Number of events 181 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	6.6% 5/76 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Spontaneous haematoma	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Thrombocytopenia	14.3% 11/77 • Number of events 22 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	5.3% 4/76 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Blood and lymphatic system disorders Thrombocytosis	5.2% 4/77 • Number of events 8 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Angina pectoris	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Aortic valve thickening	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Arrhythmia	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Atrial fibrillation	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Bundle branch block right	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Supraventricular extrasystoles	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Cardiac disorders Tachycardia	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Ear and labyrinth disorders Ear pain	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Ear and labyrinth disorders Vertigo	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Eye disorders Dry eye	1.3% 1/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Eye disorders Eye pain	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Eye disorders Eye pruritus	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Eye disorders Lacrimation increased	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	5.3% 4/76 • Number of events 5 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Eye disorders Vision blurred	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Abdominal discomfort	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Abdominal pain	11.7% 9/77 • Number of events 18 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	7.9% 6/76 • Number of events 7 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Abdominal pain lower	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Abdominal pain upper	2.6% 2/77 • Number of events 3 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 3 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Anal fissure	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Anal inflammation	0.00% 0/77 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Aphthous ulcer	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Chronic gastritis	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Constipation	16.9% 13/77 • Number of events 21 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	19.7% 15/76 • Number of events 17 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Diarrhoea	51.9% 40/77 • Number of events 91 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	40.8% 31/76 • Number of events 64 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Dry mouth	2.6% 2/77 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	7.9% 6/76 • Number of events 7 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Dyschezia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Dyspepsia	7.8% 6/77 • Number of events 7 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	2.6% 2/76 • Number of events 2 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Dysphagia	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Eructation	2.6% 2/77 • Number of events 3 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	1.3% 1/76 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose
Gastrointestinal disorders Gastrointestinal motility disorder	1.3% 1/77 • Number of events 1 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose	0.00% 0/76 • All Adverse Events (AE) were collected from the informed consent signature up to the final visit regardless of seriousness or relationship to study drug (maximum exposure: 82 weeks). Reported AEs are Treatment-Emergent AEs (TEAE) that are AEs that developed/worsened during the treatment period i.e. between the first treatment intake date and the last treatment intake date + 35 days. In the Capecitabine + bevacizumab group, the number of participants at Risk for TEAE (both serious and non-serious) was 76 which is different from Started patients in the Participant Flow module (=77). Indeed, 1 started patient in this group did not received any treatment dose