Trial Outcomes & Findings for Atezolizumab Immunotherapy in Patients With Advanced NSCLC (NCT NCT03102242)
NCT ID: NCT03102242
Last Updated: 2023-05-24
Results Overview
The primary objective of this single arm phase II trial is to determine whether neoadjuvant and adjuvant anti-PD-L1 therapy bracketing standard chemoradiation therapy and consolidation therapy is worthy of further investigation. The primary endpoint will be the disease control rate (DCR) after 12 weeks induction immunotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-05-24
Participant Flow
Participant milestones
| Measure |
Arm A (Treatment)
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Treatment)
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Atezolizumab Immunotherapy in Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Arm A (Treatment)
n=62 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Age, Continuous
|
63.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe primary objective of this single arm phase II trial is to determine whether neoadjuvant and adjuvant anti-PD-L1 therapy bracketing standard chemoradiation therapy and consolidation therapy is worthy of further investigation. The primary endpoint will be the disease control rate (DCR) after 12 weeks induction immunotherapy.
Outcome measures
| Measure |
Arm A (Treatment)
n=62 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Disease Control Rate (DCR) After 12 Weeks Induction
|
0.742 proportion of participants
Interval 0.657 to 0.814
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
Objective response rate (ORR) is the rate of best overall response (complete or partial response) after 12 weeks of neoadjuvant atezolizumab therapy. ORR and its 90% Clopper-Pearson Confidence interval will be estimated.
Outcome measures
| Measure |
Arm A (Treatment)
n=62 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Objective Response Rate (ORR)
|
0.661 proportion of participants
Interval 0.573 to 0.761
|
SECONDARY outcome
Timeframe: 38.3 monthsProgression-free survival (PFS) is defined as the time from the start of neoadjuvant therapy to disease progression or recurrence (first disease recurrence or death, whichever comes first). The Kaplan-Meier estimator will be used to estimate median PFS and confidence intervals.
Outcome measures
| Measure |
Arm A (Treatment)
n=64 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Median PFS
|
26.1 Months
Interval 15.8 to
Not enough events to calculate upper interval.
|
SECONDARY outcome
Timeframe: 12 and 24 MonthsProgression-free survival (PFS) is defined as the time from the start of neoadjuvant therapy to disease progression or recurrence (first disease recurrence or death, whichever comes first). The Kaplan-Meier estimator will be used to estimate median PFS and confidence intervals. A progression occurs when at least one of the following are true: 1. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (\< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. 2. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD (Section 11.4.1). In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD. 3. See Section 11.3.2 for details in regards to the requirements for PD via FDG-PET imaging.
Outcome measures
| Measure |
Arm A (Treatment)
n=64 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Progression Free Survival (PFS) at 12 and 24 Months
12
|
0.66 proportion of participants
Interval 0.56 to 0.79
|
|
Progression Free Survival (PFS) at 12 and 24 Months
24
|
0.5 proportion of participants
Interval 0.39 to 0.66
|
SECONDARY outcome
Timeframe: 38.3 MonthsOverall Survival (OS) is defined as the time from the start of neoadjuvant therapy to death. The Kaplan-Meier estimator will be used to estimate median OS.
Outcome measures
| Measure |
Arm A (Treatment)
n=64 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Median OS
|
NA Months
Not enough events for calculation of median or confidence intervals
|
SECONDARY outcome
Timeframe: 12 and 24 MonthsOverall Survival (OS) is defined as the time from the start of neoadjuvant therapy to death. The Kaplan-Meier estimator will be used to estimate OS at 12 months and 24 months, and their confidence intervals.
Outcome measures
| Measure |
Arm A (Treatment)
n=64 Participants
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Overall Survival at 12 and 24 Months
12 months
|
0.87 proportion of participants
Interval 0.79 to 0.96
|
|
Overall Survival at 12 and 24 Months
24 months
|
0.73 proportion of participants
Interval 0.62 to 0.85
|
Adverse Events
Arm A (Treatment)
Serious events: 34 serious events
Other events: 59 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Arm A (Treatment)
n=64 participants at risk
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Cardiac disorders
Heart failure
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Cardiac disorders
Pericardial effusion
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Endocrine disorders
Adrenal insufficiency
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Colitis
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Esophageal stenosis
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
General disorders
Fever
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
General disorders
Flu like symptoms
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Immune system disorders
Anaphylaxis
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Biliary tract infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Lung infection
|
12.5%
8/64 • Number of events 8 • 38.3 Months
|
|
Infections and infestations
Sepsis
|
6.2%
4/64 • Number of events 5 • 38.3 Months
|
|
Infections and infestations
Skin infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Upper respiratory infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.7%
3/64 • Number of events 5 • 38.3 Months
|
|
Investigations
Platelet count decreased
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
White blood cell decreased
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Brachial plexopathy
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Stroke
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Syncope
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Psychiatric disorders
Delirium
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.8%
5/64 • Number of events 5 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Vascular disorders
Superior vena cava syndrome
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Vascular disorders
Thromboembolic event
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
Other adverse events
| Measure |
Arm A (Treatment)
n=64 participants at risk
Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy.
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
35.9%
23/64 • Number of events 31 • 38.3 Months
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.2%
11/64 • Number of events 13 • 38.3 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
10.9%
7/64 • Number of events 14 • 38.3 Months
|
|
Gastrointestinal disorders
Gingival pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.7%
3/64 • Number of events 5 • 38.3 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
8/64 • Number of events 15 • 38.3 Months
|
|
Gastrointestinal disorders
Nausea
|
53.1%
34/64 • Number of events 46 • 38.3 Months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Oral pain
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Gastrointestinal disorders
Stomach pain
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Vomiting
|
26.6%
17/64 • Number of events 24 • 38.3 Months
|
|
General disorders
Chills
|
17.2%
11/64 • Number of events 12 • 38.3 Months
|
|
General disorders
Edema face
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
General disorders
Edema limbs
|
17.2%
11/64 • Number of events 18 • 38.3 Months
|
|
General disorders
Edema trunk
|
3.1%
2/64 • Number of events 4 • 38.3 Months
|
|
General disorders
Facial pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
General disorders
Fatigue
|
65.6%
42/64 • Number of events 90 • 38.3 Months
|
|
General disorders
Fever
|
17.2%
11/64 • Number of events 12 • 38.3 Months
|
|
General disorders
Flu like symptoms
|
3.1%
2/64 • Number of events 3 • 38.3 Months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
4.7%
3/64 • Number of events 5 • 38.3 Months
|
|
General disorders
Infusion site extravasation
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
General disorders
Localized edema
|
3.1%
2/64 • Number of events 3 • 38.3 Months
|
|
General disorders
Malaise
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
General disorders
Neck edema
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
General disorders
Non-cardiac chest pain
|
25.0%
16/64 • Number of events 22 • 38.3 Months
|
|
General disorders
Pain
|
29.7%
19/64 • Number of events 31 • 38.3 Months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Conjunctivitis
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Infections and infestations
Eye infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
9.4%
6/64 • Number of events 8 • 38.3 Months
|
|
Infections and infestations
Lung infection
|
10.9%
7/64 • Number of events 9 • 38.3 Months
|
|
Infections and infestations
Mucosal infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Papulopustular rash
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Paronychia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Sinusitis
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Infections and infestations
Skin infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Infections and infestations
Upper respiratory infection
|
15.6%
10/64 • Number of events 15 • 38.3 Months
|
|
Infections and infestations
Urinary tract infection
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Infections and infestations
Vaginal infection
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
14.1%
9/64 • Number of events 11 • 38.3 Months
|
|
Cardiac disorders
Chest pain - cardiac
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Cardiac disorders
Heart failure
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Cardiac disorders
Palpitations
|
9.4%
6/64 • Number of events 6 • 38.3 Months
|
|
Cardiac disorders
Pericardial effusion
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Cardiac disorders
Sinus tachycardia
|
23.4%
15/64 • Number of events 15 • 38.3 Months
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Ear and labyrinth disorders
Ear pain
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Endocrine disorders
Hyperthyroidism
|
7.8%
5/64 • Number of events 6 • 38.3 Months
|
|
Endocrine disorders
Hypothyroidism
|
10.9%
7/64 • Number of events 8 • 38.3 Months
|
|
Eye disorders
Blurred vision
|
12.5%
8/64 • Number of events 9 • 38.3 Months
|
|
Eye disorders
Dry eye
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Eye disorders
Eye disorders - Other, specify
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Eye disorders
Floaters
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Eye disorders
Optic nerve disorder
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Eye disorders
Watering eyes
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
10/64 • Number of events 19 • 38.3 Months
|
|
Gastrointestinal disorders
Bloating
|
7.8%
5/64 • Number of events 5 • 38.3 Months
|
|
Gastrointestinal disorders
Colitis
|
4.7%
3/64 • Number of events 6 • 38.3 Months
|
|
Gastrointestinal disorders
Constipation
|
40.6%
26/64 • Number of events 42 • 38.3 Months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
24/64 • Number of events 46 • 38.3 Months
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Gastrointestinal disorders
Dysphagia
|
23.4%
15/64 • Number of events 19 • 38.3 Months
|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
28/64 • Number of events 74 • 38.3 Months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Gastrointestinal disorders
Esophageal pain
|
3.1%
2/64 • Number of events 3 • 38.3 Months
|
|
Gastrointestinal disorders
Esophageal stenosis
|
3.1%
2/64 • Number of events 4 • 38.3 Months
|
|
Gastrointestinal disorders
Esophageal ulcer
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
4/64 • Number of events 5 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
4/64 • Number of events 6 • 38.3 Months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
Alanine aminotransferase increased
|
15.6%
10/64 • Number of events 12 • 38.3 Months
|
|
Investigations
Alkaline phosphatase increased
|
9.4%
6/64 • Number of events 8 • 38.3 Months
|
|
Investigations
Aspartate aminotransferase increased
|
21.9%
14/64 • Number of events 16 • 38.3 Months
|
|
Investigations
Blood bilirubin increased
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Investigations
Cardiac troponin I increased
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
Cholesterol high
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
Creatinine increased
|
10.9%
7/64 • Number of events 15 • 38.3 Months
|
|
Investigations
ECG QT corrected interval prolonged
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
Ejection fraction decreased
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Investigations
INR increased
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Investigations
Investigations - Other, specify
|
7.8%
5/64 • Number of events 5 • 38.3 Months
|
|
Investigations
Lymphocyte count decreased
|
29.7%
19/64 • Number of events 94 • 38.3 Months
|
|
Investigations
Neutrophil count decreased
|
12.5%
8/64 • Number of events 18 • 38.3 Months
|
|
Investigations
Platelet count decreased
|
23.4%
15/64 • Number of events 45 • 38.3 Months
|
|
Investigations
Weight gain
|
9.4%
6/64 • Number of events 13 • 38.3 Months
|
|
Investigations
Weight loss
|
18.8%
12/64 • Number of events 21 • 38.3 Months
|
|
Investigations
White blood cell decreased
|
28.1%
18/64 • Number of events 52 • 38.3 Months
|
|
Metabolism and nutrition disorders
Acidosis
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
20/64 • Number of events 30 • 38.3 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
18.8%
12/64 • Number of events 13 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.7%
3/64 • Number of events 5 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.4%
6/64 • Number of events 11 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.6%
1/64 • Number of events 3 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.2%
11/64 • Number of events 19 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.2%
11/64 • Number of events 18 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
8/64 • Number of events 16 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.3%
13/64 • Number of events 20 • 38.3 Months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
16/64 • Number of events 25 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
12/64 • Number of events 19 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.1%
9/64 • Number of events 12 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
10.9%
7/64 • Number of events 10 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.3%
13/64 • Number of events 16 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
8/64 • Number of events 10 • 38.3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Brachial plexopathy
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Concentration impairment
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Dizziness
|
18.8%
12/64 • Number of events 14 • 38.3 Months
|
|
Nervous system disorders
Dysarthria
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Dysgeusia
|
10.9%
7/64 • Number of events 8 • 38.3 Months
|
|
Nervous system disorders
Facial muscle weakness
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Headache
|
26.6%
17/64 • Number of events 22 • 38.3 Months
|
|
Nervous system disorders
Lethargy
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Memory impairment
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Nervous system disorders
Movements involuntary
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Nervous system disorders
Muscle weakness right-sided
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
6.2%
4/64 • Number of events 7 • 38.3 Months
|
|
Nervous system disorders
Paresthesia
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.6%
26/64 • Number of events 37 • 38.3 Months
|
|
Nervous system disorders
Presyncope
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Somnolence
|
3.1%
2/64 • Number of events 3 • 38.3 Months
|
|
Nervous system disorders
Syncope
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Nervous system disorders
Tremor
|
4.7%
3/64 • Number of events 4 • 38.3 Months
|
|
Psychiatric disorders
Agitation
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
|
Psychiatric disorders
Anxiety
|
15.6%
10/64 • Number of events 10 • 38.3 Months
|
|
Psychiatric disorders
Depression
|
12.5%
8/64 • Number of events 9 • 38.3 Months
|
|
Psychiatric disorders
Insomnia
|
26.6%
17/64 • Number of events 20 • 38.3 Months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Psychiatric disorders
Restlessness
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Renal and urinary disorders
Hematuria
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Renal and urinary disorders
Urinary frequency
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Renal and urinary disorders
Urinary tract pain
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Renal and urinary disorders
Urinary urgency
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.3%
29/64 • Number of events 53 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
51.6%
33/64 • Number of events 66 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.6%
1/64 • Number of events 3 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
8/64 • Number of events 9 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.8%
5/64 • Number of events 6 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
4/64 • Number of events 5 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.6%
10/64 • Number of events 10 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
4/64 • Number of events 5 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
21.9%
14/64 • Number of events 20 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
20.3%
13/64 • Number of events 35 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.1%
2/64 • Number of events 2 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.8%
5/64 • Number of events 6 • 38.3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
18.8%
12/64 • Number of events 16 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.7%
19/64 • Number of events 29 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.1%
9/64 • Number of events 10 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.8%
5/64 • Number of events 5 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
12/64 • Number of events 13 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
4/64 • Number of events 4 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.3%
13/64 • Number of events 22 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
9.4%
6/64 • Number of events 9 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Vascular disorders
Hot flashes
|
4.7%
3/64 • Number of events 3 • 38.3 Months
|
|
Vascular disorders
Hypertension
|
32.8%
21/64 • Number of events 39 • 38.3 Months
|
|
Vascular disorders
Hypotension
|
14.1%
9/64 • Number of events 12 • 38.3 Months
|
|
Vascular disorders
Phlebitis
|
1.6%
1/64 • Number of events 1 • 38.3 Months
|
|
Vascular disorders
Thromboembolic event
|
7.8%
5/64 • Number of events 5 • 38.3 Months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.6%
1/64 • Number of events 2 • 38.3 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place