Trial Outcomes & Findings for A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma (NCT NCT02852655)
NCT ID: NCT02852655
Last Updated: 2025-03-13
Results Overview
To measure changes in tumor infiltrating T lymphocyte (TIL) density, defined as % total cells. It will be assessed using pooled Group A and Group B patients.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
2 weeks. TIL density is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after Neoadjuvant Day 1.
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
Group A (Stage 1): Neoadjuvant + Adjuvant MK3475
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group A Expansion Cohort (Stage 2): Neoadjuvant + Adjuvant MK3475
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B (Stage 1): Adjuvant MK3475
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|---|
|
Registered and Ready to Initiate Tx
STARTED
|
16
|
25
|
19
|
|
Registered and Ready to Initiate Tx
COMPLETED
|
16
|
25
|
16
|
|
Registered and Ready to Initiate Tx
NOT COMPLETED
|
0
|
0
|
3
|
|
Receive NeoAdjuvant Protocol Tx
STARTED
|
16
|
25
|
16
|
|
Receive NeoAdjuvant Protocol Tx
COMPLETED
|
16
|
25
|
16
|
|
Receive NeoAdjuvant Protocol Tx
NOT COMPLETED
|
0
|
0
|
0
|
|
Complete Surgical Resection
STARTED
|
16
|
25
|
16
|
|
Complete Surgical Resection
COMPLETED
|
16
|
25
|
16
|
|
Complete Surgical Resection
NOT COMPLETED
|
0
|
0
|
0
|
|
Eligible to Initiate Adjuvant MK3475
STARTED
|
16
|
25
|
16
|
|
Eligible to Initiate Adjuvant MK3475
COMPLETED
|
15
|
22
|
14
|
|
Eligible to Initiate Adjuvant MK3475
NOT COMPLETED
|
1
|
3
|
2
|
|
Adjuvant MK3475 Therapy
STARTED
|
15
|
22
|
14
|
|
Adjuvant MK3475 Therapy
COMPLETED
|
0
|
0
|
0
|
|
Adjuvant MK3475 Therapy
NOT COMPLETED
|
15
|
22
|
14
|
Reasons for withdrawal
| Measure |
Group A (Stage 1): Neoadjuvant + Adjuvant MK3475
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group A Expansion Cohort (Stage 2): Neoadjuvant + Adjuvant MK3475
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B (Stage 1): Adjuvant MK3475
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|---|
|
Registered and Ready to Initiate Tx
Patient deemed ineligible due to high decadron dose
|
0
|
0
|
1
|
|
Registered and Ready to Initiate Tx
Withdrawal by Subject
|
0
|
0
|
2
|
|
Eligible to Initiate Adjuvant MK3475
Disease Progression
|
1
|
2
|
2
|
|
Eligible to Initiate Adjuvant MK3475
Surgery showed no evidence of recurrence (only treatment related changes)
|
0
|
1
|
0
|
|
Adjuvant MK3475 Therapy
Disease Progression
|
13
|
21
|
12
|
|
Adjuvant MK3475 Therapy
Adverse Event
|
1
|
0
|
0
|
|
Adjuvant MK3475 Therapy
Withdrawal by Subject
|
0
|
1
|
1
|
|
Adjuvant MK3475 Therapy
Still on Active Study Therapy
|
1
|
0
|
0
|
|
Adjuvant MK3475 Therapy
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
Group A (Stage 1): Neoadjuvant + Adjuvant MK3475
n=16 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group A Expansion Cohort (Stage 2): Neoadjuvant + Adjuvant MK3475
n=25 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B (Stage 1): Adjuvant MK3475
n=16 Participants
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
21-29 years old
|
1 years
n=5 Participants
|
1 years
n=7 Participants
|
0 years
n=5 Participants
|
2 years
n=4 Participants
|
|
Age, Customized
30-39 years old
|
2 years
n=5 Participants
|
2 years
n=7 Participants
|
2 years
n=5 Participants
|
6 years
n=4 Participants
|
|
Age, Customized
40-49 years old
|
1 years
n=5 Participants
|
6 years
n=7 Participants
|
0 years
n=5 Participants
|
7 years
n=4 Participants
|
|
Age, Customized
50-59 years old
|
3 years
n=5 Participants
|
3 years
n=7 Participants
|
5 years
n=5 Participants
|
11 years
n=4 Participants
|
|
Age, Customized
60-69 years old
|
9 years
n=5 Participants
|
10 years
n=7 Participants
|
6 years
n=5 Participants
|
25 years
n=4 Participants
|
|
Age, Customized
70 +
|
0 years
n=5 Participants
|
3 years
n=7 Participants
|
3 years
n=5 Participants
|
6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
25 participants
n=7 Participants
|
16 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Baseline Karnofsky Performance Status (KPS)
KPS = 70
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Baseline Karnofsky Performance Status (KPS)
KPS = 80
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Baseline Karnofsky Performance Status (KPS)
KPS = 90
|
3 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Baseline Karnofsky Performance Status (KPS)
KPS = 100
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Current Relapse #
1st Relapse
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Current Relapse #
2nd Relapse
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
0 mg/day
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
1 mg/day
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
2 mg/day
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
3 mg/day
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
4 mg/day
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Total Daily Steroid Dose at Registration (mg/day)
6 mg/day
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
MGMT Methylation Status
MGMT Methylated
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
MGMT Methylation Status
MGMT Unmethylated
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
MGMT Methylation Status
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
IDH1/2 Mutation Status
Negative
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
IDH1/2 Mutation Status
Positive
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
IDH1/2 Mutation Status
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeks. TIL density is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after Neoadjuvant Day 1.Population: Group A = Initial Group A Cohort (Stage 1) + Group A Expansion Cohort (Stage 2) Group B = Initial Group B Cohort (Stage 1)
To measure changes in tumor infiltrating T lymphocyte (TIL) density, defined as % total cells. It will be assessed using pooled Group A and Group B patients.
Outcome measures
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=37 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=15 Participants
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* \* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Tumor Infiltrating T Lymphocyte (TIL) Density
|
2.2 percentage of total stromal area
Standard Error 0.32
|
2.1 percentage of total stromal area
Standard Error 0.63
|
PRIMARY outcome
Timeframe: 2 weeks. Cell cycle/cancer proliferation genetic signature is determined in surgical tumor tissue; on-study surgery occurs 14 days (+/- 5 days) after Neoadjuvant Day 1.Population: Group A = Initial Group A Cohort (Stage 1) + Group A Expansion Cohort (Stage 2) Group B = Initial Group B Cohort (Stage 1)
To measure changes in cell cycle and cancer proliferation genetic signature; these results are reported using Gene Set Variation Analysis (GSVA) absolute enrichment scores (ES). GSVA scores are unit-less scores derived by comparing mRNA expression of a specific gene set to genes outside of the gene set in a sample. In this case, GSVA scores for "Farmers\_breast\_cancer\_cluster\_2, as previously described" were utilized. PMID 30742122 (https://pubmed.ncbi.nlm.nih.gov/30742122/) and PMID 23323831 (https://pubmed.ncbi.nlm.nih.gov/23323831/) It will be assessed using pooled Group A and Group B patients.
Outcome measures
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=34 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=15 Participants
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* \* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Cell Cycle and Cancer Proliferation Genetic Signature
|
-0.1758 unitless
Standard Error 0.08192
|
0.3008 unitless
Standard Error 0.1472
|
PRIMARY outcome
Timeframe: 5 years. Although there is still 1 patient on active study treatment as of today (4/1/2024), we stopped looking at this information as of 6/2/2022 for study reporting purposes.Population: All patients who received at least one dose of pembrolizumab on study are included in this analysis. Group A = Initial Group A Cohort (Stage 1) + Group A Expansion Cohort (Stage 2) Group B = Initial Group B Cohort (Stage 1)
Number of Participants who Experienced a Serious Adverse Event (SAE) or Event of Clinical Interest (ECI) Deemed At Least Possibly Related to Pembrolizumab (MK3475). The following are measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations.
Outcome measures
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=41 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=16 Participants
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* \* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
Patients Experiencing an SAE Deemed At Least Possibly Related to Pembrolizumab
|
13 Participants
|
5 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Patients Experiencing an ECI Deemed At Least Possibly Related to Pembrolizumab
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 DaysPopulation: Censoring \& Final PFS #s: • Group A patients censored from PFS Analysis: o 1 patient's on study surgery did not show recurrent disease (53) Group A = Initial Stage 1 Cohort + Stage 2 Expansion Cohort Group B = Initial Stage 1 Cohort * 1 patient's histology did not confirm diagnosis of GBM (28) * 3 patients' disease was considered unevaluable (47, 49, \& 60) • Group B patients censored from PFS Analysis: * 1 patient's on study surgery did not show recurrent disease (13)
To determine the efficacy of pembrolizumab in patients with surgically accessible recurrent/progressive glioblastoma (GBM) participants as measured by 6-month progression-free survival (PFS6) using Radiologic Assessment in Neuro-Oncology (RANO) criteria. Progression is defined using RANO criteria, as any of the following: 1. ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement, on stable or increasing doses of corticosteroids 2. Any new enhancing measurable lesion 3. Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose 4. Or failure to return for evaluation as a result of death or deteriorating condition
Outcome measures
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=36 Participants
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=15 Participants
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* \* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
5 Participants
|
2 Participants
|
Adverse Events
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
Serious events: 18 serious events
Other events: 40 other events
Deaths: 37 deaths
Group B: Adjuvant MK3475 (Stage 1 Cohort)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=41 participants at risk
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=16 participants at risk
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Death NOS
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Fatigue
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Gait disturbance
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Edema cerebral
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Seizure
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Confusion
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Fever
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Failure to Thrive
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Infections and infestations
Vulval infection
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Lethargy
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Left-sided neglect
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Reproductive system and breast disorders
Vaginal pain
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Craniotomy
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
Other adverse events
| Measure |
Group A: Neoadjuvant + Adjuvant MK3475 (Stage 1 Cohort + Stage 2 Expansion Cohort)
n=41 participants at risk
* Single dose of Pembrolizumab (MK3475) @ 200 mg IV
* Surgery within 14 days (+/- 5 days) of Neoadjuvant dose
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
Group B: Adjuvant MK3475 (Stage 1 Cohort)
n=16 participants at risk
* Surgery (NO pre-surgical drug)
* Adjuvant Pembrolizumab (MK3475) @ 200 mg IV every 3 weeks to start upon recovery from surgery (and no more than 35 days after surgery) until disease progression or unacceptable toxicity.
* Pembrolizumab (MK-3475) administered intravenously over 30 minutes (-5 min/+10 min)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
39.0%
16/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
43.8%
7/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Cardiac disorders
Sinus bradycardia
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Cardiac disorders
Sinus tachycardia
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Endocrine disorders
Hyperthyroidism
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Endocrine disorders
Hypothyroidism
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Eye disorders
Blurred vision
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Eye disorders
Dry eye
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Eye disorders
Optic nerve disorder
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Eye disorders
Eye disorders - Other, specify: Double Vision
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Constipation
|
14.6%
6/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
37.5%
6/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Diarrhea
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Dysphagia
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
13/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
50.0%
8/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
6/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Edema face
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Edema limbs
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Edema trunk
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Facial pain
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Fatigue
|
43.9%
18/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
75.0%
12/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Fever
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Gait disturbance
|
36.6%
15/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
25.0%
4/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Localized edema
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Malaise
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
General disorders
Pain
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Infections and infestations
Infections and infestations - Other, specify: Propionibacterium acnes - CNS
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Injury, poisoning and procedural complications
Bruising
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Injury, poisoning and procedural complications
Fall
|
19.5%
8/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Alanine aminotransferase increased
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Alkaline phosphatase increased
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Aspartate aminotransferase increased
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Cholesterol high
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Creatinine increased
|
14.6%
6/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
INR increased
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Lymphocyte count decreased
|
34.1%
14/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
56.2%
9/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Neutrophil count decreased
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
25.0%
4/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Platelet count decreased
|
22.0%
9/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
31.2%
5/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
Weight gain
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Investigations
White blood cell decreased
|
19.5%
8/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
31.2%
5/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.5%
8/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.6%
15/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
50.0%
8/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.5%
8/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
43.8%
7/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
31.7%
13/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
31.2%
5/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
37.5%
6/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
9/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
26.8%
11/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
31.2%
5/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Ataxia
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Cognitive disturbance
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Concentration impairment
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dizziness
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
25.0%
4/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dysarthria
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dysesthesia
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dysgeusia
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Dysphasia
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
25.0%
4/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Edema cerebral
|
22.0%
9/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Facial muscle weakness
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Headache
|
56.1%
23/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
56.2%
9/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Memory impairment
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Paresthesia
|
14.6%
6/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
25.0%
4/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Seizure
|
31.7%
13/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
18.8%
3/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Somnolence
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Tremor
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Tumor Flair
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: left slowed finger tapping
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Left pronator drift
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: left visual field cut
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Agitation
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Anxiety
|
17.1%
7/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Confusion
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Depression
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Insomnia
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
31.2%
5/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Personality change
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Proteinuria
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Urinary frequency
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Renal and urinary disorders
Urinary urgency
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
8/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
37.5%
6/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders, Other: Respiratory Syncytial Virus
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
12.5%
2/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.2%
5/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
7.3%
3/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
0.00%
0/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: IVC filter placement
|
2.4%
1/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Vascular disorders
Hypertension
|
24.4%
10/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
|
Vascular disorders
Thromboembolic event
|
9.8%
4/41 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
6.2%
1/16 • Adverse Events (AEs) on this trial have been monitored/assessed for up to 6 years (the maximum amount of time a patient has remained on active study treatment). AEs are collected from the time of treatment registration through 30 days following end of study treatment. AEs meeting serious criteria, from the time of consent through 90 days following end of study treatment, or initiation of new anti-cancer therapy, whichever is earlier.
An AE is any untoward medical occurrence in a subject receiving study treatment, regardless of event causality. An SAE is an AE at any dose that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is a new cancer, is associated with an overdose, or is an important medical event. One Group A subject was lost-to-follow-up, so was tracked for a shorter duration.
|
Additional Information
Jose R. McFaline Figueroa, MD, PhD
Dana-Farber Cancer Institute
Phone: 617-632-2166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place