Trial Outcomes & Findings for To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid (NCT NCT00617409)
NCT ID: NCT00617409
Last Updated: 2019-11-08
Results Overview
Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
12 months
Results posted on
2019-11-08
Participant Flow
Participant milestones
| Measure |
Standard of Care
Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Ad.p53-DC Vaccines
Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Ad.p53-DC Vaccines + ATRA
Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
31
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
27
|
Reasons for withdrawal
| Measure |
Standard of Care
Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Ad.p53-DC Vaccines
Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Ad.p53-DC Vaccines + ATRA
Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
3
|
|
Overall Study
Disease Progression
|
8
|
8
|
18
|
|
Overall Study
Death
|
3
|
5
|
4
|
|
Overall Study
Alternative Therapy
|
1
|
2
|
0
|
Baseline Characteristics
To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid
Baseline characteristics by cohort
| Measure |
Arm A - Active Comparator
n=18 Participants
Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Arm B - Experimental
n=20 Participants
Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Arm C - Experimental
n=31 Participants
Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
|
Age, Continuous
|
63 years
n=39 Participants
|
63 years
n=41 Participants
|
62.45 years
n=35 Participants
|
62.75 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
36 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=39 Participants
|
20 participants
n=41 Participants
|
31 participants
n=35 Participants
|
69 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants.
Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Ad.p53-DC Vaccines
n=20 Participants
Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Ad.p53-DC Vaccines + ATRA
n=31 Participants
Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
|
|---|---|---|---|
|
Tumor Response Rate (RR)
Overall Response
|
8 participants
|
6 participants
|
12 participants
|
|
Tumor Response Rate (RR)
Progressive Disease
|
1 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All participants.
To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.
Outcome measures
| Measure |
Standard of Care
n=18 Participants
Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Ad.p53-DC Vaccines
n=20 Participants
Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Ad.p53-DC Vaccines + ATRA
n=31 Participants
Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
|
|---|---|---|---|
|
Overall Survival (OS)
|
12.17 months
Interval 9.27 to 18.83
|
6.32 months
Interval 5.13 to 13.93
|
6.20 months
Interval 4.17 to 11.57
|
Adverse Events
Arm A - Active Comparator
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm B - Experimental
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm C - Experimental
Serious events: 12 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Active Comparator
n=18 participants at risk
Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Arm B - Experimental
n=20 participants at risk
Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Arm C - Experimental
n=31 participants at risk
Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
|
|---|---|---|---|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Leukopenia/Anemia
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Death NOS
|
0.00%
0/18 • 6 years, 6 months
|
15.0%
3/20 • Number of events 3 • 6 years, 6 months
|
16.1%
5/31 • Number of events 5 • 6 years, 6 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Pain - Chest wall
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Rigors/chills
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Infections and infestations
Febrile neutopenia
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Mucosa
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Investigations
Leukocytes (total WBC) - low
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Investigations
Platelets - low
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Pain - Head/headache
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Nervous system disorders
Seizure
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Psychiatric disorders
Suicide attempt
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/18 • 6 years, 6 months
|
30.0%
6/20 • Number of events 7 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, COPD
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Pneumonia
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Vascular disorders
Vessel injury-artery - Other NOS
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
Other adverse events
| Measure |
Arm A - Active Comparator
n=18 participants at risk
Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
|
Arm B - Experimental
n=20 participants at risk
Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
|
Arm C - Experimental
n=31 participants at risk
Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Edema: limb
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drugrelated hemolysis)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) - Low
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 6 • 6 years, 6 months
|
16.1%
5/31 • Number of events 11 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
9.7%
3/31 • Number of events 9 • 6 years, 6 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - Low
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Ear and labyrinth disorders
Auditory/Ear - Other, Hearing loss
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Eye disorders
Ocular/Visual - Other, Keratotic lesion-left side
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Eye disorders
Ocular/Visual - Other, Right sided ptosis
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Eye disorders
Vision-blurred vision
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Anorexia
|
38.9%
7/18 • Number of events 11 • 6 years, 6 months
|
25.0%
5/20 • Number of events 6 • 6 years, 6 months
|
38.7%
12/31 • Number of events 15 • 6 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
20.0%
4/20 • Number of events 4 • 6 years, 6 months
|
16.1%
5/31 • Number of events 6 • 6 years, 6 months
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 3 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
29.0%
9/31 • Number of events 10 • 6 years, 6 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • Number of events 3 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Esophagitis
|
16.7%
3/18 • Number of events 3 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Flatulance
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other, Decrease color in stools
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other, GI virus
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other, Increased burping
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/18 • 6 years, 6 months
|
10.0%
2/20 • Number of events 3 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Number of events 4 • 6 years, 6 months
|
15.0%
3/20 • Number of events 3 • 6 years, 6 months
|
45.2%
14/31 • Number of events 22 • 6 years, 6 months
|
|
Gastrointestinal disorders
Pain - Absomen NOS
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 3 • 6 years, 6 months
|
12.9%
4/31 • Number of events 5 • 6 years, 6 months
|
|
Gastrointestinal disorders
Pain - Esophagus
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Pain - Other, Pain at distal margins
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Pain - Stomach
|
5.6%
1/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 3 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
29.0%
9/31 • Number of events 13 • 6 years, 6 months
|
|
General disorders
Fatigue
|
44.4%
8/18 • Number of events 12 • 6 years, 6 months
|
65.0%
13/20 • Number of events 19 • 6 years, 6 months
|
71.0%
22/31 • Number of events 29 • 6 years, 6 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Flu-like syndrome
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
General disorders
Pain - Face
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 4 • 6 years, 6 months
|
|
General disorders
Pain - Other, Upper quadrant
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Pain - Pain NOS
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Rigors/chills
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
General disorders
Sweating (diaphoresis)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
6.5%
2/31 • Number of events 3 • 6 years, 6 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/18 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Investigations
Creatinine - High
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Investigations
Hemoglobin - Low
|
16.7%
3/18 • Number of events 3 • 6 years, 6 months
|
20.0%
4/20 • Number of events 5 • 6 years, 6 months
|
19.4%
6/31 • Number of events 15 • 6 years, 6 months
|
|
Investigations
Lipase increased
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Investigations
Metabolic/Laboratory - Other, Elevated AST
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Investigations
Platelets - Low
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
15.0%
3/20 • Number of events 3 • 6 years, 6 months
|
19.4%
6/31 • Number of events 14 • 6 years, 6 months
|
|
Investigations
Weight loss
|
22.2%
4/18 • Number of events 4 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
11.1%
2/18 • Number of events 3 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
12.9%
4/31 • Number of events 7 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase) - High
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
12.9%
4/31 • Number of events 5 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Amylase
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
22.2%
4/18 • Number of events 4 • 6 years, 6 months
|
25.0%
5/20 • Number of events 5 • 6 years, 6 months
|
25.8%
8/31 • Number of events 18 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
16.1%
5/31 • Number of events 8 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, Hyperlipidemia
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, Decreased HDL
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, Decreased protein
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, High total protein
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, Hyperglycemia
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other, Increased ALT
|
5.6%
1/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 2 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
6.5%
2/31 • Number of events 3 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/18 • 6 years, 6 months
|
10.0%
2/20 • Number of events 4 • 6 years, 6 months
|
19.4%
6/31 • Number of events 9 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremitylower
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
11.1%
2/18 • Number of events 3 • 6 years, 6 months
|
25.0%
5/20 • Number of events 7 • 6 years, 6 months
|
16.1%
5/31 • Number of events 5 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
22.6%
7/31 • Number of events 10 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
15.0%
3/20 • Number of events 3 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
16.7%
3/18 • Number of events 4 • 6 years, 6 months
|
10.0%
2/20 • Number of events 3 • 6 years, 6 months
|
16.1%
5/31 • Number of events 8 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
12.9%
4/31 • Number of events 4 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
11.1%
2/18 • Number of events 3 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
19.4%
6/31 • Number of events 6 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Other, Flank
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Other, Hip
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Other, Rib/Rib cage
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Other, Shoulder
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 3 • 6 years, 6 months
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Nervous system disorders
Dizziness
|
22.2%
4/18 • Number of events 4 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
9.7%
3/31 • Number of events 3 • 6 years, 6 months
|
|
Nervous system disorders
Memory Impairment
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Neurology - Other, Numbness in lower legs and feet
|
5.6%
1/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Nervous system disorders
Neuropathy: cranial - CN IX Motor-pharynx; Sensory-ear, pharynx, tongue
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 2 • 6 years, 6 months
|
|
Nervous system disorders
Neuropathy: cranial - CN VIII Hearing and balance
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Nervous system disorders
Neuropathy: sensory
|
16.7%
3/18 • Number of events 4 • 6 years, 6 months
|
15.0%
3/20 • Number of events 4 • 6 years, 6 months
|
29.0%
9/31 • Number of events 14 • 6 years, 6 months
|
|
Nervous system disorders
Pain - Head/headache
|
16.7%
3/18 • Number of events 4 • 6 years, 6 months
|
20.0%
4/20 • Number of events 4 • 6 years, 6 months
|
71.0%
22/31 • Number of events 65 • 6 years, 6 months
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Number of events 2 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
12.9%
4/31 • Number of events 5 • 6 years, 6 months
|
|
Psychiatric disorders
Mental status
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Psychiatric disorders
Mood alteration - Depression
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Renal and urinary disorders
Obstruction, GU - Ureter
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Renal and urinary disorders
Urine color change
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Reproductive system and breast disorders
Pain - Breast
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Reproductive system and breast disorders
Pain - Pelvis
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
8/18 • Number of events 10 • 6 years, 6 months
|
45.0%
9/20 • Number of events 10 • 6 years, 6 months
|
35.5%
11/31 • Number of events 16 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
9/18 • Number of events 11 • 6 years, 6 months
|
55.0%
11/20 • Number of events 17 • 6 years, 6 months
|
45.2%
14/31 • Number of events 20 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage/Bleeding - Other, Hemoptysis
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pleura
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Wheezing
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Absent breath sounds-right base
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Congestion
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other, erythema- chest wall and scalp
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other, Tightness of skin on hands
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
19.4%
6/31 • Number of events 11 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
16.7%
3/18 • Number of events 5 • 6 years, 6 months
|
15.0%
3/20 • Number of events 4 • 6 years, 6 months
|
22.6%
7/31 • Number of events 11 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
0.00%
0/18 • 6 years, 6 months
|
15.0%
3/20 • Number of events 4 • 6 years, 6 months
|
12.9%
4/31 • Number of events 4 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pain - Scalp
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
10.0%
2/20 • Number of events 2 • 6 years, 6 months
|
16.1%
5/31 • Number of events 6 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
9.7%
3/31 • Number of events 4 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
6.5%
2/31 • Number of events 4 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Radiation
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
3.2%
1/31 • Number of events 1 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/18 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
6.5%
2/31 • Number of events 3 • 6 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
11.1%
2/18 • Number of events 2 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 6 years, 6 months
|
5.0%
1/20 • Number of events 1 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
|
Vascular disorders
Vascular - Other, Chronic venous stasis in legs
|
5.6%
1/18 • Number of events 1 • 6 years, 6 months
|
0.00%
0/20 • 6 years, 6 months
|
0.00%
0/31 • 6 years, 6 months
|
Additional Information
Dr. Scott Antonia
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3883
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place