Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer (NCT NCT00089479)

NCT ID: NCT00089479

Last Updated: 2012-12-21

Results Overview

Number of patients with/without recurrence of breast cancer, or death due to any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2611 participants
• Primary outcome timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
• Results posted on: 2012-12-21

Participant Flow

Participant milestones

Measure	AC Then T Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Overall Study STARTED	1304	1307
Overall Study Received Treatment	1305	1283
Overall Study COMPLETED	973	1018
Overall Study NOT COMPLETED	331	289

Reasons for withdrawal

Measure	AC Then T Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Overall Study Death	108	75
Overall Study Withdrawal by Subject	86	107
Overall Study Lost to Follow-up	137	107

Baseline Characteristics

A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

Baseline characteristics by cohort

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles	Total n=2611 Participants Total of all reporting groups
Age Continuous	51.2 years STANDARD_DEVIATION 8.81 • n=5 Participants	50.6 years STANDARD_DEVIATION 9.19 • n=7 Participants	50.9 years STANDARD_DEVIATION 9.00 • n=5 Participants
Sex: Female, Male Female	1304 Participants n=5 Participants	1307 Participants n=7 Participants	2611 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Number of patients with/without recurrence of breast cancer, or death due to any cause.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival [Number of Events] Patients without events	1140 participants	1167 participants
Disease Free Survival [Number of Events] Patients with event	164 participants	140 participants

PRIMARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival [Time to Event]	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.

SECONDARY outcome

Timeframe: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Number of patients who died/were alive.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Overall Survival [Number of Events] Patients with event	108 participants	75 participants
Overall Survival [Number of Events] Patients without events	1196 participants	1232 participants

SECONDARY outcome

Timeframe: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Overall Survival [Time to Event]	NA months The median time to death based on Kaplan-Meier estimates was not reached in this adjuvant trial due to low death rate.	NA months The median time to death based on Kaplan-Meier estimates was not reached in this adjuvant trial due to low death rate.

SECONDARY outcome

Timeframe: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .

Population: Intent-to-Treat Population

Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Breast Cancer Free Survival [Number of Events] Patients with event	158 participants	144 participants
Breast Cancer Free Survival [Number of Events] Patients without events	1146 participants	1163 participants

SECONDARY outcome

Timeframe: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Breast Cancer Free Survival [Time to Event]	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.

SECONDARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] Patients with event	169 participants	154 participants
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] Patients without events	1135 participants	1153 participants

SECONDARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.

SECONDARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival Including Any New Cancer as Event [Number of Events] Patients with event	200 participants	177 participants
Disease Free Survival Including Any New Cancer as Event [Number of Events] Patients without events	1104 participants	1130 participants

SECONDARY outcome

Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Population: Intent-to-Treat Population

Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Outcome measures

Measure	AC Then T n=1304 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1307 Participants Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Disease Free Survival Including Any New Cancer as Event [Time to Event]	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.	NA months The median time to event based on Kaplan-Meier estimates was not reached in this adjuvant trial.

Adverse Events

AC Then T

Serious events: 264 serious events

Other events: 1301 other events

Deaths: 0 deaths

AC Then XT

Serious events: 200 serious events

Other events: 1283 other events

Deaths: 0 deaths

Serious adverse events

Measure	AC Then T n=1305 participants at risk Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1283 participants at risk Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	9.0% 118/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.2% 80/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders NEUTROPENIA	0.77% 10/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.86% 11/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.39% 5/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders LEUKOPENIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations CELLULITIS	0.84% 11/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.47% 6/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PNEUMONIA	0.77% 10/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.31% 4/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations SEPSIS	0.38% 5/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations INFECTION	0.31% 4/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations DEVICE RELATED INFECTION	0.31% 4/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations NEUTROPENIC INFECTION	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations BREAST CELLULITIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations BREAST INFECTION	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations BRONCHITIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations NEUTROPENIC SEPSIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations URINARY TRACT INFECTION	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations WOUND INFECTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations BREAST ABSCESS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations GASTROENTERITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations SINUSITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations ABSCESS LIMB	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations ACUTE SINUSITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations APPENDICITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations BACTERIAL SEPSIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations CLOSTRIDIAL INFECTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations DEVICE RELATED SEPSIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations DIVERTICULITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations FEBRILE INFECTION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations FUNGAL SKIN INFECTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations HISTOPLASMOSIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations MASTITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations MENINGITIS BACTERIAL	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations ORAL HERPES	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations OTITIS MEDIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PAROTITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PERIDIVERTICULAR ABSCESS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PHARYNGITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PLEURAL INFECTION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PNEUMONIA PRIMARY ATYPICAL	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations SOFT TISSUE INFECTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations TOOTH ABSCESS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders VOMITING	1.00% 13/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.39% 5/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders DIARRHOEA	0.77% 10/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.31% 4/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders NAUSEA	0.54% 7/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.47% 6/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders STOMATITIS ALL	0.31% 4/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.47% 6/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ABDOMINAL PAIN	0.38% 5/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders COLITIS	0.23% 3/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders CONSTIPATION	0.23% 3/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders GASTRITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ENTEROCUTANEOUS FISTULA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders GASTRITIS EROSIVE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ILEUS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders OESOPHAGITIS ULCERATIVE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders PANCREATITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders PYREXIA	1.6% 21/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.70% 9/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders CHEST PAIN	0.38% 5/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.86% 11/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders ASTHENIA	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders FATIGUE	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders HERNIA OBSTRUCTIVE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders NON-CARDIAC CHEST PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders THROMBOSIS IN DEVICE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders CATHETER SITE PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders CHEST DISCOMFORT	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders DEVICE DISLOCATION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders MEDICAL DEVICE COMPLICATION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders OEDEMA PERIPHERAL	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders DEHYDRATION	0.84% 11/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	1.4% 18/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.31% 4/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.38% 5/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.39% 5/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.23% 3/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders ALVEOLITIS ALLERGIC	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders COUGH	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders DEEP VEIN THROMBOSIS	0.61% 8/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.55% 7/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders HYPOTENSION	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders THROMBOSIS	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders AORTITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders HYPERTENSION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders VENOUS OCCLUSION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders SYNCOPE	0.38% 5/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders CONVULSION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.23% 3/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders HEADACHE	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders MIGRAINE	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders CEREBRAL INFARCTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders DIZZINESS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders BONE PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders COMPARTMENT SYNDROME	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MYOSITIS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders MYOCARDIAL INFARCTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders ANGINA UNSTABLE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders CARDIOMYOPATHY	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders CARDIOMYOPATHY ACUTE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders PALPITATIONS	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Cardiac disorders TACHYCARDIA	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications COMPRESSION FRACTURE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications OVERDOSE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders BREAST MASS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders MENOMETRORRHAGIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders MENORRHAGIA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders PELVIC PAIN	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Reproductive system and breast disorders VAGINAL LACERATION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders RASH	0.15% 2/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders SKIN DISORDER	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Surgical and medical procedures BREAST RECONSTRUCTION	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Surgical and medical procedures LYMPHADENECTOMY	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Surgical and medical procedures NEOPLASM PROPHYLAXIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Surgical and medical procedures PROPHYLAXIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Surgical and medical procedures SIMPLE MASTECTOMY	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO MENINGES	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders DEPRESSION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders ANXIETY	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders CONFUSIONAL STATE	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Immune system disorders HYPERSENSITIVITY	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.16% 2/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Renal and urinary disorders NEPHROLITHIASIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Renal and urinary disorders URINARY RETENTION	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Hepatobiliary disorders CHOLECYSTITIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Hepatobiliary disorders CHOLELITHIASIS	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Ear and labyrinth disorders VERTIGO	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.08% 1/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Social circumstances BREAST PROSTHESIS USER	0.08% 1/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	0.00% 0/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.

Other adverse events

Measure	AC Then T n=1305 participants at risk Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	AC Then XT n=1283 participants at risk Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles
Gastrointestinal disorders NAUSEA	86.2% 1125/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	87.1% 1118/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders STOMATITIS ALL	65.0% 848/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	76.4% 980/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders DIARRHOEA	44.5% 581/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	59.2% 759/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders VOMITING	47.4% 618/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	46.1% 591/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders CONSTIPATION	42.3% 552/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	46.5% 596/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders DYSPEPSIA	22.1% 289/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	30.3% 389/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ABDOMINAL PAIN	12.2% 159/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	19.4% 249/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders DRY MOUTH	6.3% 82/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	11.4% 146/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders DYSPHAGIA	5.0% 65/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	10.4% 133/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	7.2% 94/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.7% 86/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders HAEMORRHOIDS	7.0% 91/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.8% 87/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	4.9% 64/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.9% 101/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ORAL PAIN	5.0% 65/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.8% 87/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders ABDOMINAL DISTENSION	3.2% 42/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.4% 69/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Gastrointestinal disorders FLATULENCE	2.4% 31/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.5% 70/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders ALOPECIA	85.3% 1113/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	83.3% 1069/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR	17.8% 232/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	60.7% 779/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders NAIL DISORDER	33.2% 433/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	38.3% 491/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders RASH	27.4% 357/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	24.6% 316/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders DRY SKIN	9.6% 125/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	13.8% 177/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders ERYTHEMA	7.1% 93/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	10.7% 137/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Skin and subcutaneous tissue disorders PRURITUS	6.7% 88/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.6% 98/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders FATIGUE	86.1% 1123/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	90.2% 1157/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders PYREXIA	28.3% 369/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	26.4% 339/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders OEDEMA PERIPHERAL	24.8% 324/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	23.8% 305/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders ASTHENIA	15.0% 196/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	14.0% 179/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders OEDEMA	14.1% 184/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	10.8% 139/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders CHILLS	11.3% 147/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	12.9% 165/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders PAIN	8.7% 114/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	9.0% 116/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
General disorders CHEST PAIN	6.4% 83/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.9% 89/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders NEUTROPENIA	74.0% 966/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	75.1% 964/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders ANAEMIA	55.9% 729/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	52.0% 667/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders LEUKOPENIA	37.6% 491/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	34.5% 443/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Blood and lymphatic system disorders THROMBOCYTOPENIA	6.7% 87/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.1% 66/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders DYSGEUSIA	34.5% 450/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	41.6% 534/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders HEADACHE	31.6% 413/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	36.2% 464/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders NEUROPATHY PERIPHERAL	25.1% 327/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	20.2% 259/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders DIZZINESS	15.7% 205/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	20.1% 258/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	17.4% 227/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	14.6% 187/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders PARAESTHESIA	8.4% 109/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.7% 99/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Nervous system disorders HYPOAESTHESIA	5.2% 68/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	3.9% 50/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MYALGIA	51.4% 671/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	44.1% 566/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders ARTHRALGIA	47.2% 616/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	39.2% 503/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders BONE PAIN	16.7% 218/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	13.8% 177/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	14.3% 186/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	14.6% 187/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders BACK PAIN	12.7% 166/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	11.8% 152/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.3% 69/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	4.8% 61/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders COUGH	22.6% 295/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	23.5% 302/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	17.0% 222/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	20.1% 258/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	18.9% 246/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	16.7% 214/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	6.8% 89/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	11.4% 146/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	8.7% 113/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.6% 97/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	4.7% 61/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.1% 78/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders DECREASED APPETITE	33.7% 440/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	35.5% 455/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPERGLYCAEMIA	23.4% 306/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	21.7% 278/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders DEHYDRATION	10.0% 131/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	8.6% 110/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Metabolism and nutrition disorders HYPOKALAEMIA	5.2% 68/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.8% 75/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	12.6% 165/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	12.4% 159/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations CANDIDIASIS	8.6% 112/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	10.4% 134/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations SINUSITIS	8.1% 106/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	8.0% 103/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations URINARY TRACT INFECTION	8.1% 106/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.6% 98/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations PHARYNGITIS	5.4% 70/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	9.3% 119/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations ORAL CANDIDIASIS	6.4% 84/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.5% 84/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations RHINITIS	5.1% 66/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.1% 78/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	5.7% 75/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	4.4% 56/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders INSOMNIA	29.2% 381/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	30.9% 397/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders DEPRESSION	16.7% 218/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	14.2% 182/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Psychiatric disorders ANXIETY	16.4% 214/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	14.3% 183/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations NEUTROPHIL COUNT DECREASED	10.1% 132/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	9.2% 118/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations WHITE BLOOD CELL COUNT DECREASED	9.0% 117/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	9.0% 116/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.7% 101/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	9.6% 123/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	6.4% 83/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	8.1% 104/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations HAEMOGLOBIN DECREASED	7.1% 93/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	6.6% 85/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Investigations WEIGHT DECREASED	5.1% 67/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	3.9% 50/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders HOT FLUSH	28.6% 373/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	27.0% 347/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders FLUSHING	8.7% 114/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	12.3% 158/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Vascular disorders LYMPHOEDEMA	9.5% 124/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.5% 71/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Eye disorders LACRIMATION INCREASED	34.6% 452/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	30.9% 396/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Eye disorders VISION BLURRED	5.7% 74/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	7.4% 95/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Ear and labyrinth disorders EAR PAIN	5.0% 65/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	5.4% 69/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
Renal and urinary disorders DYSURIA	5.9% 77/1305 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.	3.7% 48/1283 • Length of study Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER