Trial Outcomes & Findings for Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide (NCT NCT00632853)

NCT ID: NCT00632853

Last Updated: 2023-06-12

Results Overview

Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.

• Recruitment status: UNKNOWN
• Study phase: PHASE3
• Target enrollment: 731 participants
• Primary outcome timeframe: 11.25 years
• Results posted on: 2023-06-12

Participant Flow

Participant milestones

Measure	Arm A Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)\> XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> * Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days\> Standard Radiation Dose Therapy: 45 Gy	Arm B Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)\> XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm C Radiotherapy (every day, Monday-Friday, for a total of 5 weeks)\> XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 16\> days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)\> Cisplatin 80 mg/m2 IV on day 1, every 21 days\> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Overall Study STARTED	313	325	93
Overall Study COMPLETED	313	325	93
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Baseline characteristics by cohort

Measure	Arm A n=313 Participants Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)\> XRT: 45 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm B n=325 Participants Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)\> XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm C n=93 Participants Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)\> XRT: 61.2 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Total n=731 Participants Total of all reporting groups
Age, Continuous	63.3 years n=93 Participants	62.4 years n=4 Participants	61.7 years n=27 Participants	62.7 years n=483 Participants
Sex: Female, Male Female	159 Participants n=93 Participants	170 Participants n=4 Participants	46 Participants n=27 Participants	375 Participants n=483 Participants
Sex: Female, Male Male	154 Participants n=93 Participants	155 Participants n=4 Participants	47 Participants n=27 Participants	356 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants	9 Participants n=4 Participants	5 Participants n=27 Participants	25 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	292 Participants n=93 Participants	302 Participants n=4 Participants	85 Participants n=27 Participants	679 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants	14 Participants n=4 Participants	3 Participants n=27 Participants	27 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	27 Participants n=93 Participants	27 Participants n=4 Participants	11 Participants n=27 Participants	65 Participants n=483 Participants
Race (NIH/OMB) White	271 Participants n=93 Participants	281 Participants n=4 Participants	80 Participants n=27 Participants	632 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=93 Participants	10 Participants n=4 Participants	0 Participants n=27 Participants	19 Participants n=483 Participants

PRIMARY outcome

Timeframe: 11.25 years

Population: All registered patients were included in this analysis.

Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.

Outcome measures

Measure	Arm A n=313 Participants Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days Standard Radiation Dose Therapy: 45 Gy	Arm B n=325 Participants Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks\> Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks):\> Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days\> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm C n=93 Participants Radiotherapy (every day, Monday-Friday, for a total of 5 weeks)\> XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 16\> days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)\> Cisplatin 80 mg/m2 IV on day 1, every 21 days\> Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Overall Survival Time	28.7 Months Interval 26.2 to 35.5	30.5 Months Interval 24.4 to 39.6	32.3 Months Interval 21.1 to 44.8

SECONDARY outcome

Timeframe: 11.25 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 4 serious events

Other events: 292 other events

Deaths: 206 deaths

Arm B

Serious events: 11 serious events

Other events: 296 other events

Deaths: 220 deaths

Arm C

Serious events: 4 serious events

Other events: 87 other events

Deaths: 73 deaths

Serious adverse events

Measure	Arm A n=313 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm B n=325 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm C n=93 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Cardiac disorder	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Death NOS	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Multi-organ failure	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Sudden death	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Immune system disorders Hypersensitivity	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sepsis(gr 3/4 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sepsis(unknown ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.

Other adverse events

Measure	Arm A n=313 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm B n=325 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days	Arm C n=93 participants at risk \- Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Blood and lymphatic system disorders Blood disorder	2.2% 7/313 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Blood and lymphatic system disorders Febrile neutropenia	13.1% 41/313 • Number of events 51 • Adverse events were collected over 15 months and mortality was collected over 140 months.	12.0% 39/325 • Number of events 44 • Adverse events were collected over 15 months and mortality was collected over 140 months.	11.8% 11/93 • Number of events 13 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Blood and lymphatic system disorders Hemoglobin decreased	78.6% 246/313 • Number of events 681 • Adverse events were collected over 15 months and mortality was collected over 140 months.	76.0% 247/325 • Number of events 660 • Adverse events were collected over 15 months and mortality was collected over 140 months.	78.5% 73/93 • Number of events 206 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Blood and lymphatic system disorders Hemolysis	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Atrial fibrillation	1.9% 6/313 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.5% 8/325 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Atrial flutter	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Atrioventricular block first degree	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Cardiac pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Cardiopulmonary arrest	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Conduction disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Left ventricular failure	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Myocardial ischemia	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Palpitations	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Right ventricular dysfunction	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Sinus bradycardia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Sinus tachycardia	1.3% 4/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Cardiac disorders Ventricular tachycardia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Ear and labyrinth disorders Ear disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Ear and labyrinth disorders Ear pain	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Ear and labyrinth disorders Hearing impaired	1.3% 4/313 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.5% 5/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Ear and labyrinth disorders Tinnitus	2.2% 7/313 • Number of events 13 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.5% 8/325 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Endocrine disorders Hypothyroidism	0.32% 1/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Dry eye syndrome	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Eye disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Optic nerve disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Photophobia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Vision blurred	1.9% 6/313 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Eye disorders Watering eyes	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Abdominal pain	1.6% 5/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.1% 10/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Colitis	0.96% 3/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Colonic perforation	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Constipation	7.0% 22/313 • Number of events 34 • Adverse events were collected over 15 months and mortality was collected over 140 months.	8.9% 29/325 • Number of events 50 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Diarrhea	6.4% 20/313 • Number of events 23 • Adverse events were collected over 15 months and mortality was collected over 140 months.	8.0% 26/325 • Number of events 35 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Dry mouth	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Duodenal perforation	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Dyspepsia	3.2% 10/313 • Number of events 15 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.4% 11/325 • Number of events 21 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.4% 5/93 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Dysphagia	51.4% 161/313 • Number of events 317 • Adverse events were collected over 15 months and mortality was collected over 140 months.	55.4% 180/325 • Number of events 361 • Adverse events were collected over 15 months and mortality was collected over 140 months.	55.9% 52/93 • Number of events 120 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Esophageal mucositis (clin exam)	0.64% 2/313 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Esophageal mucositis (funct/sympt)	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Esophageal pain	56.5% 177/313 • Number of events 358 • Adverse events were collected over 15 months and mortality was collected over 140 months.	50.5% 164/325 • Number of events 323 • Adverse events were collected over 15 months and mortality was collected over 140 months.	53.8% 50/93 • Number of events 110 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Esophageal stenosis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Esophagitis	5.8% 18/313 • Number of events 23 • Adverse events were collected over 15 months and mortality was collected over 140 months.	14.2% 46/325 • Number of events 78 • Adverse events were collected over 15 months and mortality was collected over 140 months.	8.6% 8/93 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Flatulence	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Gastric hemorrhage	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Gastritis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Gastrointestinal disorder	1.3% 4/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.8% 9/325 • Number of events 19 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Gingival pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Hemorrhoids	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Ileus	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Mucositis oral (clin exam)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Mucositis oral (funct/sympt)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Nausea	59.7% 187/313 • Number of events 392 • Adverse events were collected over 15 months and mortality was collected over 140 months.	57.8% 188/325 • Number of events 416 • Adverse events were collected over 15 months and mortality was collected over 140 months.	66.7% 62/93 • Number of events 142 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Oral pain	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Pancreatitis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Rectal pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Small intestinal obstruction	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Stomach pain	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Gastrointestinal disorders Vomiting	29.4% 92/313 • Number of events 150 • Adverse events were collected over 15 months and mortality was collected over 140 months.	32.3% 105/325 • Number of events 169 • Adverse events were collected over 15 months and mortality was collected over 140 months.	47.3% 44/93 • Number of events 72 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Chest pain	3.2% 10/313 • Number of events 14 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.9% 16/325 • Number of events 17 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Chills	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Edema limbs	1.9% 6/313 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.5% 8/325 • Number of events 16 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Fatigue	21.1% 66/313 • Number of events 141 • Adverse events were collected over 15 months and mortality was collected over 140 months.	23.4% 76/325 • Number of events 168 • Adverse events were collected over 15 months and mortality was collected over 140 months.	28.0% 26/93 • Number of events 52 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Fever	3.2% 10/313 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Flu-like symptoms	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Gait abnormal	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders General symptom	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 13 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Hypothermia	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Ill-defined disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Injection site reaction	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Localized edema	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
General disorders Pain	2.6% 8/313 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.2% 17/325 • Number of events 22 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Hepatobiliary disorders Cholecystitis	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Immune system disorders Cytokine release syndrome	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Immune system disorders Hypersensitivity	3.5% 11/313 • Number of events 26 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 14/325 • Number of events 22 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.4% 5/93 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Immune system disorders Immune system disorder	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Abdominal infection	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Bladder infection(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Bronchitis(gr 0/1/2 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Bronchitis(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Bronchitis(unknown ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Catheter related infection	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Catheter related infection(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Colitis, infectious	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Encephalitis infection(gr 0/1/2 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Endocarditis infective(gr 3/4 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Esophageal infection(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Esophageal infection(unknown ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Eye infection(unknown ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Gingival infection(gr 0/1/2 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Infection(gr 0/1/2 ANC)	3.5% 11/313 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.7% 12/325 • Number of events 14 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Infectious colitis(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Kidney infection(gr 0/1/2 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Mucosal infection(unknown ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Opportunistic infection	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Otitis externa(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Paranasal sinus infection(gr 0/1/2 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Peritoneal infection(gr 3/4 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Pharyngitis	0.96% 3/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Pneumonia(gr 0/1/2 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Pneumonia(gr 3/4 ANC)	1.3% 4/313 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Pneumonia(unknown ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sepsis(gr 0/1/2 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sepsis(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sepsis(unknown ANC)	2.2% 7/313 • Number of events 9 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Sinusitis(gr 0/1/2 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Skin infection	0.96% 3/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Soft tissue infection(gr 3/4 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Tooth infection	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Tooth infection(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Upper respiratory infection(gr 3/4 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Upr aerodigstve trct infctn(unknown ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Urinary tract infection(gr 0/1/2 ANC)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Urinary tract infection(gr 3/4 ANC)	0.96% 3/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Urinary tract infection(unknown ANC)	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Infections and infestations Wound infection(gr 3/4 ANC)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Aortic injury	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Bruising	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Dermatitis radiation	1.3% 4/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.6% 15/325 • Number of events 27 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Fracture	0.64% 2/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Intraoperative renal injury	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	19.5% 61/313 • Number of events 93 • Adverse events were collected over 15 months and mortality was collected over 140 months.	27.7% 90/325 • Number of events 148 • Adverse events were collected over 15 months and mortality was collected over 140 months.	25.8% 24/93 • Number of events 42 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Injury, poisoning and procedural complications Vascular access complication	1.6% 5/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Activated partial throm time prolonged	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Alanine aminotransferase increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Alkaline phosphatase increased	1.3% 4/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Aspartate aminotransferase increased	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Blood bilirubin increased	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations CD4 lymphocytes decreased	0.96% 3/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.5% 8/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Cardiac troponin I increased	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Cardiac troponin T increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Creatinine increased	26.8% 84/313 • Number of events 155 • Adverse events were collected over 15 months and mortality was collected over 140 months.	28.0% 91/325 • Number of events 168 • Adverse events were collected over 15 months and mortality was collected over 140 months.	21.5% 20/93 • Number of events 37 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Electrocardiogram QTc interval prolonged	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations INR increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Laboratory test abnormal	1.3% 4/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Leukocyte count decreased	70.0% 219/313 • Number of events 480 • Adverse events were collected over 15 months and mortality was collected over 140 months.	72.6% 236/325 • Number of events 559 • Adverse events were collected over 15 months and mortality was collected over 140 months.	78.5% 73/93 • Number of events 174 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Lipase increased	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Lymphocyte count decreased	12.1% 38/313 • Number of events 68 • Adverse events were collected over 15 months and mortality was collected over 140 months.	16.0% 52/325 • Number of events 109 • Adverse events were collected over 15 months and mortality was collected over 140 months.	22.6% 21/93 • Number of events 34 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Neutrophil count decreased	68.1% 213/313 • Number of events 411 • Adverse events were collected over 15 months and mortality was collected over 140 months.	73.8% 240/325 • Number of events 530 • Adverse events were collected over 15 months and mortality was collected over 140 months.	76.3% 71/93 • Number of events 168 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Platelet count decreased	20.1% 63/313 • Number of events 96 • Adverse events were collected over 15 months and mortality was collected over 140 months.	23.4% 76/325 • Number of events 127 • Adverse events were collected over 15 months and mortality was collected over 140 months.	22.6% 21/93 • Number of events 38 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Serum cholesterol increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Weight gain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Investigations Weight loss	38.3% 120/313 • Number of events 236 • Adverse events were collected over 15 months and mortality was collected over 140 months.	36.6% 119/325 • Number of events 227 • Adverse events were collected over 15 months and mortality was collected over 140 months.	44.1% 41/93 • Number of events 86 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Acidosis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Anorexia	8.6% 27/313 • Number of events 43 • Adverse events were collected over 15 months and mortality was collected over 140 months.	9.2% 30/325 • Number of events 44 • Adverse events were collected over 15 months and mortality was collected over 140 months.	16.1% 15/93 • Number of events 17 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Blood glucose increased	6.4% 20/313 • Number of events 30 • Adverse events were collected over 15 months and mortality was collected over 140 months.	8.6% 28/325 • Number of events 58 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 15 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Blood uric acid increased	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Dehydration	33.5% 105/313 • Number of events 158 • Adverse events were collected over 15 months and mortality was collected over 140 months.	33.2% 108/325 • Number of events 178 • Adverse events were collected over 15 months and mortality was collected over 140 months.	36.6% 34/93 • Number of events 59 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Iron overload	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Obesity	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum albumin decreased	4.2% 13/313 • Number of events 14 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 14/325 • Number of events 28 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.4% 5/93 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum calcium decreased	1.6% 5/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.2% 17/325 • Number of events 25 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum calcium increased	0.32% 1/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum glucose decreased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum magnesium decreased	6.7% 21/313 • Number of events 32 • Adverse events were collected over 15 months and mortality was collected over 140 months.	8.6% 28/325 • Number of events 52 • Adverse events were collected over 15 months and mortality was collected over 140 months.	9.7% 9/93 • Number of events 19 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum magnesium increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum phosphate decreased	1.3% 4/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum potassium decreased	8.6% 27/313 • Number of events 31 • Adverse events were collected over 15 months and mortality was collected over 140 months.	13.5% 44/325 • Number of events 60 • Adverse events were collected over 15 months and mortality was collected over 140 months.	16.1% 15/93 • Number of events 20 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum potassium increased	1.3% 4/313 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 9 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum sodium decreased	10.9% 34/313 • Number of events 45 • Adverse events were collected over 15 months and mortality was collected over 140 months.	12.3% 40/325 • Number of events 66 • Adverse events were collected over 15 months and mortality was collected over 140 months.	10.8% 10/93 • Number of events 15 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum sodium increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Metabolism and nutrition disorders Serum triglycerides increased	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Back pain	2.2% 7/313 • Number of events 19 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.4% 11/325 • Number of events 18 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Chest wall pain	0.32% 1/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.2% 3/93 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Muscle weakness	3.2% 10/313 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.8% 9/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.2% 3/93 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Myalgia	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.5% 5/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Neck pain	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.5% 5/325 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Depressed level of consciousness	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Dizziness	4.2% 13/313 • Number of events 20 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.2% 17/325 • Number of events 26 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Dysgeusia	1.3% 4/313 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 13 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Encephalopathy	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Facial muscle weakness	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Facial nerve disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Headache	3.8% 12/313 • Number of events 15 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 14/325 • Number of events 30 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.2% 3/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Intracranial hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Memory impairment	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Neuralgia	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Neurological disorder NOS	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Peripheral motor neuropathy	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Peripheral sensory neuropathy	17.6% 55/313 • Number of events 113 • Adverse events were collected over 15 months and mortality was collected over 140 months.	18.5% 60/325 • Number of events 134 • Adverse events were collected over 15 months and mortality was collected over 140 months.	21.5% 20/93 • Number of events 36 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Radiculitis brachial	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Seizure	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Syncope	3.2% 10/313 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.5% 8/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.2% 3/93 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Syncope vasovagal	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Nervous system disorders Tremor	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Psychiatric disorders Agitation	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Psychiatric disorders Anxiety	1.6% 5/313 • Number of events 9 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.0% 13/325 • Number of events 19 • Adverse events were collected over 15 months and mortality was collected over 140 months.	6.5% 6/93 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Psychiatric disorders Confusion	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Psychiatric disorders Depression	2.9% 9/313 • Number of events 13 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 7/325 • Number of events 11 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Psychiatric disorders Insomnia	3.8% 12/313 • Number of events 18 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.4% 11/325 • Number of events 22 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 4/93 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Bladder hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Cystitis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Glomerular filtration rate decreased	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Proteinuria	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Renal failure	0.64% 2/313 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Urinary frequency	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Urinary incontinence	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Urinary retention	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Renal and urinary disorders Urogenital disorder	1.9% 6/313 • Number of events 10 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.5% 5/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Cough	11.2% 35/313 • Number of events 64 • Adverse events were collected over 15 months and mortality was collected over 140 months.	11.4% 37/325 • Number of events 81 • Adverse events were collected over 15 months and mortality was collected over 140 months.	10.8% 10/93 • Number of events 20 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	43.8% 137/313 • Number of events 293 • Adverse events were collected over 15 months and mortality was collected over 140 months.	50.5% 164/325 • Number of events 354 • Adverse events were collected over 15 months and mortality was collected over 140 months.	47.3% 44/93 • Number of events 92 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.2% 4/325 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.0% 13/325 • Number of events 15 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis (clin exam)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis (funct/sympt)	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 17/313 • Number of events 22 • Adverse events were collected over 15 months and mortality was collected over 140 months.	3.7% 12/325 • Number of events 24 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 7 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.3% 4/313 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Tracheal mucositis (clin exam)	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Alopecia	7.7% 24/313 • Number of events 54 • Adverse events were collected over 15 months and mortality was collected over 140 months.	9.5% 31/325 • Number of events 68 • Adverse events were collected over 15 months and mortality was collected over 140 months.	6.5% 6/93 • Number of events 14 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Dry skin	0.64% 2/313 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Pruritus	0.32% 1/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 5 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Rash acneiform	0.96% 3/313 • Number of events 4 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 3 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Rash desquamating	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Skin disorder	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.31% 1/325 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Flushing	0.32% 1/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Hemorrhage	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Hot flashes	0.00% 0/313 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.92% 3/325 • Number of events 6 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Hypertension	4.2% 13/313 • Number of events 29 • Adverse events were collected over 15 months and mortality was collected over 140 months.	5.2% 17/325 • Number of events 32 • Adverse events were collected over 15 months and mortality was collected over 140 months.	2.2% 2/93 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Hypotension	3.2% 10/313 • Number of events 12 • Adverse events were collected over 15 months and mortality was collected over 140 months.	4.3% 14/325 • Number of events 20 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Phlebitis	0.32% 1/313 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/325 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.00% 0/93 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Thrombosis	4.2% 13/313 • Number of events 19 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.8% 6/325 • Number of events 9 • Adverse events were collected over 15 months and mortality was collected over 140 months.	7.5% 7/93 • Number of events 8 • Adverse events were collected over 15 months and mortality was collected over 140 months.
Vascular disorders Vascular disorder	0.64% 2/313 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	0.62% 2/325 • Number of events 2 • Adverse events were collected over 15 months and mortality was collected over 140 months.	1.1% 1/93 • Number of events 1 • Adverse events were collected over 15 months and mortality was collected over 140 months.

Additional Information

Dr. Steven Schild

Mayo Clinic

Phone: 480-301-9692

Email: sschild@mayo.edu

Results disclosure agreements

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