Trial Outcomes & Findings for Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT01041781)
NCT ID: NCT01041781
Last Updated: 2018-07-23
Results Overview
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
313 participants
Primary outcome timeframe
Time between randomization and disease relapse or death from any cause, assessed up to 5 years
Results posted on
2018-07-23
Participant Flow
Participant milestones
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
158
|
|
Overall Study
COMPLETED
|
154
|
158
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=154 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=158 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=39 Participants
|
64.0 years
n=41 Participants
|
64.0 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=39 Participants
|
71 Participants
n=41 Participants
|
143 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=39 Participants
|
87 Participants
n=41 Participants
|
169 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
154 Participants
n=39 Participants
|
158 Participants
n=41 Participants
|
312 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Time between randomization and disease relapse or death from any cause, assessed up to 5 yearsProgression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=154 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=158 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Progression-free Survival
|
5.16 months
Interval 4.4 to 5.78
|
5.26 months
Interval 4.4 to 6.08
|
SECONDARY outcome
Timeframe: Time between randomization and death from any cause, assessed up to 5 yearsOverall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=154 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=158 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Overall Survival
|
11.4 months
Interval 9.46 to 14.06
|
12.5 months
Interval 9.36 to 13.83
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=154 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=158 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Response Rate
|
40 percentage of patients
Interval 32.0 to 48.0
|
35 percentage of patients
Interval 27.0 to 43.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=154 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=158 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0
|
61.04 percentage of patients
|
55.06 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=27 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=78 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)
|
7.7 months
Interval 4.4 to 13.14
|
4.9 months
Interval 3.81 to 6.14
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=56 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=49 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)
|
6.2 months
Interval 4.4 to 7.49
|
4.2 months
Interval 3.42 to 5.78
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=79 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=26 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)
|
6.0 months
Interval 4.5 to 7.23
|
3.0 months
Interval 1.77 to 5.09
|
Adverse Events
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
Serious events: 31 serious events
Other events: 135 other events
Deaths: 15 deaths
Arm II (Arm B: Placebo + Standard Chemotherapy)
Serious events: 21 serious events
Other events: 140 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=146 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=148 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Investigations
CPK increased
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Anemia
|
15.1%
22/146 • Number of events 26 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
11.5%
17/148 • Number of events 19 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Pericardial tamponade
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Sinus bradycardia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Ileus
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Oral pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
7/146 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Death NOS
|
3.4%
5/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fatigue
|
13.7%
20/146 • Number of events 23 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
10.1%
15/148 • Number of events 17 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fever
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Esophageal infection
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Lung infection
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Sepsis
|
2.7%
4/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alkaline phosphatase increased
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
3/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Blood bilirubin increased
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Lipase increased
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Lymphocyte count decreased
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Neutrophil count decreased
|
5.5%
8/146 • Number of events 8 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
6.1%
9/148 • Number of events 10 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
11.0%
16/146 • Number of events 17 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
8.1%
12/148 • Number of events 12 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
White blood cell decreased
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
5/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.1%
6/148 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.5%
8/146 • Number of events 8 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Cognitive disturbance
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Dizziness
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Stroke
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Depression
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Insomnia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.1%
3/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Hypotension
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Visceral arterial ischemia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
Other adverse events
| Measure |
Arm I (Arm A: Celecoxib + Standard Chemotherapy)
n=146 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
|
Arm II (Arm B: Placebo + Standard Chemotherapy)
n=148 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m\^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.2%
120/146 • Number of events 566 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
83.1%
123/148 • Number of events 490 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Palpitations
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.1%
3/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Ear and labyrinth disorders
Vertigo
|
0.68%
1/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Endocrine disorders
Hypothyroidism
|
0.68%
1/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Blurred vision
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Eye disorders
Watering eyes
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
5/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
6/146 • Number of events 10 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.4%
5/148 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
3/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.4%
5/148 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Dry mouth
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.2%
31/146 • Number of events 47 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
15.5%
23/148 • Number of events 34 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
6/146 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
7.4%
11/148 • Number of events 16 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.68%
1/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
32.9%
48/146 • Number of events 79 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
21.6%
32/148 • Number of events 48 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Edema limbs
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fatigue
|
74.7%
109/146 • Number of events 423 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
77.7%
115/148 • Number of events 418 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Fever
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Non-cardiac chest pain
|
2.7%
4/146 • Number of events 12 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
General disorders
Pain
|
3.4%
5/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 9 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Immune system disorders
Allergic reaction
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Lung infection
|
6.2%
9/146 • Number of events 12 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Mucosal infection
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Otitis media
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Skin infection
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Fall
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
4/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
2/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 10 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Blood bilirubin increased
|
3.4%
5/146 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
CD4 lymphocytes decreased
|
1.4%
2/146 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Cholesterol high
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Creatinine increased
|
0.68%
1/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Hemoglobin increased
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
INR increased
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Investigations - Other, specify
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Lymphocyte count decreased
|
8.9%
13/146 • Number of events 17 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
10.8%
16/148 • Number of events 36 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Lymphocyte count increased
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Neutrophil count decreased
|
45.2%
66/146 • Number of events 150 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
45.3%
67/148 • Number of events 138 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
52.7%
77/146 • Number of events 207 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
52.7%
78/148 • Number of events 173 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
Weight loss
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Investigations
White blood cell decreased
|
10.3%
15/146 • Number of events 20 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
10.8%
16/148 • Number of events 26 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.9%
67/146 • Number of events 160 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
43.2%
64/148 • Number of events 136 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.5%
8/146 • Number of events 13 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.4%
5/148 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
9/146 • Number of events 20 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
5.4%
8/148 • Number of events 13 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.4%
5/146 • Number of events 8 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.68%
1/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.68%
1/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
4/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.1%
6/148 • Number of events 9 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.0%
16/146 • Number of events 37 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
3.4%
5/148 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
5/146 • Number of events 10 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.7%
4/148 • Number of events 11 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
4/146 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
8.1%
12/148 • Number of events 29 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 11 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Dizziness
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Headache
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 10 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.4%
2/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
2/146 • Number of events 5 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Stroke
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Syncope
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Nervous system disorders
Tremor
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Anxiety
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Confusion
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Depression
|
0.68%
1/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Psychiatric disorders
Insomnia
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
5/146 • Number of events 7 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.8%
10/146 • Number of events 13 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
4.1%
6/148 • Number of events 9 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
3/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
3/146 • Number of events 3 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.4%
2/146 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
2/146 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.1%
22/146 • Number of events 40 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
10.1%
15/148 • Number of events 20 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.68%
1/148 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Hypertension
|
0.00%
0/146 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
2.0%
3/148 • Number of events 4 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Hypotension
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
1.4%
2/148 • Number of events 2 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
2.7%
4/146 • Number of events 6 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
5.4%
8/148 • Number of events 13 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.68%
1/146 • Number of events 1 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
0.00%
0/148 • Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place