Trial Outcomes & Findings for Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma (NCT NCT01026220)
NCT ID: NCT01026220
Last Updated: 2022-04-28
Results Overview
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
166 participants
Primary outcome timeframe
At 4 years from enrollment
Results posted on
2022-04-28
Participant Flow
Participant milestones
| Measure |
INDUCTION THERAPY (ABVE-PC)
All Patients
|
REGIMEN I (RER)
Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
|
REGIMEN II (SER)
Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Induction
STARTED
|
166
|
0
|
0
|
|
Induction
COMPLETED
|
141
|
0
|
0
|
|
Induction
NOT COMPLETED
|
25
|
0
|
0
|
|
Consolidation Maintenance
STARTED
|
0
|
81
|
80
|
|
Consolidation Maintenance
COMPLETED
|
0
|
75
|
66
|
|
Consolidation Maintenance
NOT COMPLETED
|
0
|
6
|
14
|
Reasons for withdrawal
| Measure |
INDUCTION THERAPY (ABVE-PC)
All Patients
|
REGIMEN I (RER)
Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
|
REGIMEN II (SER)
Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
|
|---|---|---|---|
|
Induction
Death
|
1
|
0
|
0
|
|
Induction
Lack of Efficacy
|
2
|
0
|
0
|
|
Induction
Physician Decision
|
12
|
0
|
0
|
|
Induction
Withdrawal by Subject
|
9
|
0
|
0
|
|
Induction
Ineligible
|
1
|
0
|
0
|
|
Consolidation Maintenance
Death
|
0
|
1
|
0
|
|
Consolidation Maintenance
Lack of Efficacy
|
0
|
1
|
1
|
|
Consolidation Maintenance
Physician Decision
|
0
|
2
|
7
|
|
Consolidation Maintenance
Withdrawal by Subject
|
0
|
2
|
6
|
Baseline Characteristics
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
INDUCTION THERAPY (ABVE-PC)
n=166 Participants
All Patients
|
|---|---|
|
Age, Categorical
<=18 years
|
156 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
15 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
143 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 4 years from enrollmentPopulation: This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
Outcome measures
| Measure |
Group 1
n=145 Participants
All Patients
|
Group 3
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Second-event-free Survival
|
0.91 Probability of survival
Interval 0.85 to 0.95
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).Population: The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.
The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.
Outcome measures
| Measure |
Group 1
n=6 Participants
All Patients
|
Group 3
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Safety Analysis and Monitoring of Toxic Death
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 years from enrollmentPopulation: 164 Group 1 All Patients received induction therapy.
Survival from enrollment to first event: relapse/progression, second malignancy, or death.
Outcome measures
| Measure |
Group 1
n=164 Participants
All Patients
|
Group 3
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Event Free Survival
|
0.81 Probability of survival
Interval 0.74 to 0.86
|
—
|
—
|
SECONDARY outcome
Timeframe: At 4 years from enrollmentPopulation: This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
Outcome measures
| Measure |
Group 1
n=77 Participants
All Patients
|
Group 3
n=68 Participants
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Second-event-free Survival
|
0.94 Probability of survival
Interval 0.84 to 0.98
|
0.88 Probability of survival
Interval 0.77 to 0.94
|
—
|
SECONDARY outcome
Timeframe: 3 years from enrollmentPopulation: RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this analysis.
To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.
Outcome measures
| Measure |
Group 1
n=77 Participants
All Patients
|
Group 3
n=57 Participants
Regimen II
|
Group 5
n=20 Participants
RER PET-1 negative
|
|---|---|---|---|
|
Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
|
0.84 Probability of survival
Interval 0.73 to 0.91
|
0.82 Probability of survival
Interval 0.69 to 0.9
|
0.90 Probability of survival
Interval 0.65 to 0.97
|
SECONDARY outcome
Timeframe: 3 years from enrollmentPopulation: 161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.
A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.
Outcome measures
| Measure |
Group 1
n=161 Participants
All Patients
|
Group 3
n=126 Participants
Regimen II
|
Group 5
n=35 Participants
RER PET-1 negative
|
|---|---|---|---|
|
Relapse-free Survival
|
0.82 Probability of survival
Interval 0.75 to 0.87
|
0.83 Probability of survival
Interval 0.75 to 0.88
|
0.79 Probability of survival
Interval 0.6 to 0.89
|
SECONDARY outcome
Timeframe: At 3 years from enrollmentPopulation: 161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.
Survival from enrollment to first event: relapse/progression, second malignancy, or death.
Outcome measures
| Measure |
Group 1
n=81 Participants
All Patients
|
Group 3
n=80 Participants
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Event Free Survival
|
0.83 Probability of survival
Interval 0.73 to 0.9
|
0.78 Probability of survival
Interval 0.67 to 0.86
|
—
|
SECONDARY outcome
Timeframe: During and after completion of study treatment.Population: 165 eligible patients.
The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.
Outcome measures
| Measure |
Group 1
n=165 Participants
All Patients
|
Group 3
Regimen II
|
Group 5
RER PET-1 negative
|
|---|---|---|---|
|
Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
|
72 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 years from enrollmentPopulation: 164 Group 1 All Patients received induction therapy. 161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.
Survival from enrollment to death.
Outcome measures
| Measure |
Group 1
n=164 Participants
All Patients
|
Group 3
n=81 Participants
Regimen II
|
Group 5
n=80 Participants
RER PET-1 negative
|
|---|---|---|---|
|
Overall Survival
|
0.97 Probability of survival
Interval 0.93 to 0.99
|
0.97 Probability of survival
Interval 0.9 to 0.99
|
0.97 Probability of survival
Interval 0.89 to 0.99
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=165 participants at risk
All Patients
|
Group 2
n=81 participants at risk
Regimen I
|
Group 3
n=80 participants at risk
Regimen II
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.6%
39/165 • Number of events 39
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
21.0%
17/81 • Number of events 17
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
27.5%
22/80 • Number of events 22
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Ear and labyrinth disorders
Ear pain
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Colitis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Esophagitis
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.7%
21/165 • Number of events 21
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
14.8%
12/81 • Number of events 12
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
11.2%
9/80 • Number of events 9
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
5/165 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Proctitis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Toothache
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
General disorders
Chills
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
General disorders
Fever
|
3.6%
6/165 • Number of events 6
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.7%
3/81 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
General disorders
Flu like symptoms
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
General disorders
Pain
|
1.8%
3/165 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Immune system disorders
Allergic reaction
|
3.0%
5/165 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
6.2%
5/81 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Appendicitis
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Bronchial infection
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Enterocolitis infectious
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.7%
3/81 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.8%
8/165 • Number of events 8
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
7.5%
6/80 • Number of events 6
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Lung infection
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Mucosal infection
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Papulopustular rash
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Pharyngitis
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Scrotal infection
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Sepsis
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Sinusitis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Skin infection
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
6/165 • Number of events 6
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
5.0%
4/80 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
GGT increased
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
Investigations - Other, specify
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
Neutrophil count decreased
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Investigations
Platelet count decreased
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.7%
3/81 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
4/165 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
5/165 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
5.0%
4/80 • Number of events 4
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
5/165 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.7%
3/81 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/80 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Nervous system disorders
Brachial plexopathy
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
3/165 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.7%
3/81 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Nervous system disorders
Syncope
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Psychiatric disorders
Anxiety
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
2/165 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/81
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/80 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Vascular disorders
Hypotension
|
3.0%
5/165 • Number of events 5
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
2.5%
2/81 • Number of events 2
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
3.8%
3/80 • Number of events 3
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
|
Vascular disorders
Thromboembolic event
|
0.61%
1/165 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
1.2%
1/81 • Number of events 1
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
0.00%
0/80
Group 1 includes all patients and the Adverse Event reports of all events across the treatment procedure. Patients who experienced induction only are also included in Group 1. After induction patients were assigned to Group 2 (RER) and Group 3 (SER). While Group 2 and Group 3 are mutually exclusive, they are subsets of Group 1. Hence the Adverse Events in Group 1 will have overlaps with Adverse Events in Group 2 and Group 3.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER