Trial Outcomes & Findings for Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer (NCT NCT01898494)
NCT ID: NCT01898494
Last Updated: 2026-04-01
Results Overview
Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
519 participants
Primary outcome timeframe
Assessed every 3 months for 2 years
Results posted on
2026-04-01
Participant Flow
The study was activated on July 9, 2013, accrued its first patient on January 22, 2014, and closed to accrual on July 7, 2017 for a total of 519 patients.
Participant milestones
| Measure |
Arm S (Transoral Surgery) Then Arm A (Observation)
Patients receive observation after transoral surgery.
|
Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy)
Patients under go transoral surgery and then receive low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
|
Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy)
Patients undergo transoral surgery and then receive standard-dose (60Gy) IMRT QD over 30 fractions.
|
Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy)
Patients undergo transoral surgery and then receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes or carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
Not Being Assigned to Step 2 Adjuvant Treatment Arms
Patients either did not receive transoral surgery at Step 1 or were not assigned to Step 2 treatment arms.
|
|---|---|---|---|---|---|
|
Step 1 (Arm S - Transoral Surgery)
STARTED
|
49
|
126
|
132
|
138
|
74
|
|
Step 1 (Arm S - Transoral Surgery)
COMPLETED
|
49
|
126
|
132
|
138
|
50
|
|
Step 1 (Arm S - Transoral Surgery)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
24
|
|
Step 2 (Adjuvant Treatment)
STARTED
|
49
|
126
|
132
|
138
|
0
|
|
Step 2 (Adjuvant Treatment)
Treated
|
49
|
120
|
127
|
134
|
0
|
|
Step 2 (Adjuvant Treatment)
Eligible and Treated
|
38
|
100
|
108
|
113
|
0
|
|
Step 2 (Adjuvant Treatment)
Eligible and Treated Patients With Baseline MDADI Assessed
|
35
|
91
|
99
|
102
|
0
|
|
Step 2 (Adjuvant Treatment)
Eligible and Treated Patients With Post-surgery MDADI Assessed
|
31
|
83
|
88
|
94
|
0
|
|
Step 2 (Adjuvant Treatment)
Eligible and Treated Patients With FACT-H&N Assessed at 6 Months
|
21
|
75
|
80
|
77
|
0
|
|
Step 2 (Adjuvant Treatment)
COMPLETED
|
49
|
119
|
118
|
127
|
0
|
|
Step 2 (Adjuvant Treatment)
NOT COMPLETED
|
0
|
7
|
14
|
11
|
0
|
Reasons for withdrawal
| Measure |
Arm S (Transoral Surgery) Then Arm A (Observation)
Patients receive observation after transoral surgery.
|
Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy)
Patients under go transoral surgery and then receive low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
|
Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy)
Patients undergo transoral surgery and then receive standard-dose (60Gy) IMRT QD over 30 fractions.
|
Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy)
Patients undergo transoral surgery and then receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes or carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
Not Being Assigned to Step 2 Adjuvant Treatment Arms
Patients either did not receive transoral surgery at Step 1 or were not assigned to Step 2 treatment arms.
|
|---|---|---|---|---|---|
|
Step 1 (Arm S - Transoral Surgery)
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
|
Step 1 (Arm S - Transoral Surgery)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Step 1 (Arm S - Transoral Surgery)
Patient ineligible
|
0
|
0
|
0
|
0
|
7
|
|
Step 1 (Arm S - Transoral Surgery)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
9
|
|
Step 1 (Arm S - Transoral Surgery)
Disease progression
|
0
|
0
|
0
|
0
|
2
|
|
Step 1 (Arm S - Transoral Surgery)
Death
|
0
|
0
|
0
|
0
|
1
|
|
Step 1 (Arm S - Transoral Surgery)
Alternative therapy
|
0
|
0
|
0
|
0
|
1
|
|
Step 1 (Arm S - Transoral Surgery)
Surgery planned but not performed
|
0
|
0
|
0
|
0
|
1
|
|
Step 2 (Adjuvant Treatment)
Adverse Event
|
0
|
0
|
2
|
3
|
0
|
|
Step 2 (Adjuvant Treatment)
Withdrawal by Subject
|
0
|
0
|
6
|
3
|
0
|
|
Step 2 (Adjuvant Treatment)
Death
|
0
|
0
|
0
|
1
|
0
|
|
Step 2 (Adjuvant Treatment)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Step 2 (Adjuvant Treatment)
Alternative therapy
|
0
|
0
|
1
|
0
|
0
|
|
Step 2 (Adjuvant Treatment)
Never started treatment
|
0
|
6
|
5
|
4
|
0
|
Baseline Characteristics
Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Total
n=359 Participants
Total of all reporting groups
|
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=38 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
Transoral surgery: Undergo transoral surgical resection
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
n=100 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
Transoral surgery: Undergo transoral surgical resection
intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
n=108 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
Transoral surgery: Undergo transoral surgical resection
intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
n=113 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes or carboplatin over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
Transoral surgery: Undergo transoral surgical resection
intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
cisplatin: Given IV
carboplatin: Given IV
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=15 Participants
|
61 years
n=5 Participants
|
59 years
n=5 Participants
|
57 years
n=10 Participants
|
58 years
n=16 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=15 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=10 Participants
|
11 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
319 Participants
n=15 Participants
|
30 Participants
n=5 Participants
|
95 Participants
n=5 Participants
|
92 Participants
n=10 Participants
|
102 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
324 Participants
n=15 Participants
|
36 Participants
n=5 Participants
|
90 Participants
n=5 Participants
|
98 Participants
n=10 Participants
|
100 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=15 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
331 Participants
n=15 Participants
|
35 Participants
n=5 Participants
|
93 Participants
n=5 Participants
|
97 Participants
n=10 Participants
|
106 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=15 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for 2 yearsPopulation: Eligible and treated patients
Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=38 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
n=100 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
n=108 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
n=113 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Progression-free Survival Rate at 2 Years
|
0.969 proportion of participants
Interval 0.919 to 1.0
|
0.949 proportion of participants
Interval 0.913 to 0.986
|
0.96 proportion of participants
Interval 0.928 to 0.993
|
0.907 proportion of participants
Interval 0.862 to 0.954
|
PRIMARY outcome
Timeframe: Assessed during surgery and directly after surgeryPopulation: Patients who received surgery
Surgery quality was evaluated based on grade 3-4 bleeding events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during surgery and positive margins after surgery. Per CTCAE v5.0, grade 3 = severe and grade 4 = life-threatening. Having grade 3-4 bleeding or positive margins indicates worse outcomes.
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=495 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins
|
0.091 proportion of participants
Interval 0.071 to 0.115
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed after directly surgeryPopulation: Patients who received surgery
Low Risk: T1-T2, N0-N1 AND clear (\> 3mm) margins, AND no extranodal extension (ENE) or PNI/LVI. Intermediate Risk: Any of the following features: one or more "close" (\< 3mm) margin(s), OR "Minimal" (\< 1mm) ENE, OR N2a (1 or more lymph node \>3cm in diameter), OR N2b (2-4 lymph nodes positive, any diameter \< 6cm), OR with perineural invastion or lymphovascular invasion. High Risk: Any of the following features: one or more positive margin(s) with any T stage, OR "Extensive" (\> 1mm) ENE, OR \> 5 metastatic lymph nodes (regardless of primary tumor margin status).
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=359 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Distribution of Histologic Risk Status
Low Risk
|
38 Participants
|
—
|
—
|
—
|
|
Distribution of Histologic Risk Status
Intermediate Risk
|
208 Participants
|
—
|
—
|
—
|
|
Distribution of Histologic Risk Status
High Risk
|
113 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baselinePopulation: Eligible and treated patients with baseline MDADI scores available
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=35 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
n=91 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
n=99 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
n=102 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
|
89.1 score on a scale
Interval 84.7 to 93.5
|
90.2 score on a scale
Interval 87.8 to 92.5
|
87.4 score on a scale
Interval 84.6 to 90.1
|
88.2 score on a scale
Interval 85.4 to 91.0
|
SECONDARY outcome
Timeframe: Assessed 4-6 weeks after surgeryPopulation: Eligible and treated patients with MDADI scores after surgery available
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=31 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
n=83 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
n=88 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
n=94 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
|
75.5 score on a scale
Interval 66.0 to 85.0
|
76.3 score on a scale
Interval 72.4 to 80.1
|
69.6 score on a scale
Interval 65.1 to 74.1
|
73.3 score on a scale
Interval 68.2 to 78.4
|
SECONDARY outcome
Timeframe: Assessed at 6 months after treatmentPopulation: Eligible and treated patients with FACT-HN total scores 6 months after treatment available
The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
Outcome measures
| Measure |
Arm S (Surgery) Then Arm A (Low Risk, Observation)
n=21 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
|
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
n=75 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
|
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
n=80 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
|
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
n=77 Participants
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|
|
Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
|
128.5 score on a scale
Interval 122.1 to 134.9
|
121.02 score on a scale
Interval 116.5 to 125.5
|
117.8 score on a scale
Interval 113.8 to 121.7
|
114.6 score on a scale
Interval 109.3 to 119.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months, up to 5 yearsProgression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 year, then every 6 months, up to 5 yearsProgression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months, up to 5 yearsProgression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival.
Outcome measures
Outcome data not reported
Adverse Events
Arm S (Transoral Surgery)
Serious events: 85 serious events
Other events: 110 other events
Deaths: 24 deaths
Arm A (Observation)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm B (Radiotherapy IMRT 50 Gy)
Serious events: 17 serious events
Other events: 57 other events
Deaths: 4 deaths
Arm C (Radiotherapy IMRT 60 Gy)
Serious events: 31 serious events
Other events: 71 other events
Deaths: 7 deaths
Arm D (Cisplatin + IMRT 66 Gy)
Serious events: 81 serious events
Other events: 96 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm S (Transoral Surgery)
n=495 participants at risk
Patients receive transoral surgery.
|
Arm A (Observation)
n=49 participants at risk
Patients receive observation after transoral surgery.
|
Arm B (Radiotherapy IMRT 50 Gy)
n=120 participants at risk
Patients with intermediate risk undergo low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
|
Arm C (Radiotherapy IMRT 60 Gy)
n=127 participants at risk
Patients with intermediate risk undergo standard-dose (60Gy) IMRT QD over 30 fractions.
|
Arm D (Cisplatin + IMRT 66 Gy)
n=134 participants at risk
High risk patients receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
5/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.5%
6/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.5%
2/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fever
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Neck edema
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Pain
|
0.61%
3/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.6%
2/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
6.3%
31/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.3%
4/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.7%
6/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
15.7%
21/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.0%
6/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.0%
14/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
20.1%
27/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.61%
3/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
3/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
10/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.2%
16/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Oral pain
|
0.81%
4/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.6%
2/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.5%
2/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.5%
2/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Wound infection
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.5%
3/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.3%
8/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.7%
9/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Intraoperative arterial injury
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.81%
4/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
3/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.7%
25/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
17.2%
23/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Weight loss
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.6%
2/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.7%
9/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
White blood cell decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.4%
22/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
2/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
3/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.0%
8/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.5%
2/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Dysphasia
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Stroke
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
3/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
1.6%
8/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.61%
3/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.81%
4/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.6%
2/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
5/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, spe
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.61%
3/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hematoma
|
1.0%
5/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hypertension
|
0.40%
2/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.5%
2/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.75%
1/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Thromboembolic event
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.20%
1/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Other adverse events
| Measure |
Arm S (Transoral Surgery)
n=495 participants at risk
Patients receive transoral surgery.
|
Arm A (Observation)
n=49 participants at risk
Patients receive observation after transoral surgery.
|
Arm B (Radiotherapy IMRT 50 Gy)
n=120 participants at risk
Patients with intermediate risk undergo low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
|
Arm C (Radiotherapy IMRT 60 Gy)
n=127 participants at risk
Patients with intermediate risk undergo standard-dose (60Gy) IMRT QD over 30 fractions.
|
Arm D (Cisplatin + IMRT 66 Gy)
n=134 participants at risk
High risk patients receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.79%
1/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.7%
9/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fatigue
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.5%
3/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
13.4%
17/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
23.1%
31/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Pain
|
5.5%
27/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.3%
4/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.1%
4/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.0%
8/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.8%
13/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
21.3%
27/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
14.2%
19/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
14.5%
72/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.0%
1/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.7%
14/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.5%
21/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
22.4%
30/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
21.7%
26/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
27.6%
35/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
32.1%
43/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.8%
7/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.7%
6/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
17.9%
24/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Oral pain
|
7.3%
36/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.8%
7/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.2%
13/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
14.2%
19/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.1%
4/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.2%
7/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
2/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.7%
6/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
10/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.8%
13/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.2%
32/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
31.3%
42/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.7%
9/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
10/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Weight loss
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.0%
12/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
15.0%
19/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.4%
34/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
White blood cell decreased
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
12.7%
17/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
9/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.9%
10/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.9%
16/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
1/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.1%
4/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
10/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
21.7%
26/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.2%
32/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.4%
34/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/495 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/49 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
2/120 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.2%
13/127 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
14.2%
19/134 • Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60