Trial Outcomes & Findings for Anti-PD-L1 in Stage IIIA(N2) Non-small Cell Lung Cancer (NSCLC) (NCT NCT02572843)
NCT ID: NCT02572843
Last Updated: 2025-10-28
Results Overview
Measured using the Kaplan-Meier method
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
at 12 months
Results posted on
2025-10-28
Participant Flow
Participant milestones
| Measure |
MEDI4736
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Accrual
STARTED
|
68
|
|
Accrual
COMPLETED
|
67
|
|
Accrual
NOT COMPLETED
|
1
|
|
Neoadjuvant chemotherapy
STARTED
|
67
|
|
Neoadjuvant chemotherapy
COMPLETED
|
62
|
|
Neoadjuvant chemotherapy
NOT COMPLETED
|
5
|
|
Neoadjuvant immunotherapy
STARTED
|
62
|
|
Neoadjuvant immunotherapy
COMPLETED
|
58
|
|
Neoadjuvant immunotherapy
NOT COMPLETED
|
4
|
|
Surgery
STARTED
|
58
|
|
Surgery
COMPLETED
|
50
|
|
Surgery
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
MEDI4736
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Accrual
Brain metastasis retrospectively detected
|
1
|
|
Neoadjuvant chemotherapy
Physician Decision
|
2
|
|
Neoadjuvant chemotherapy
Starting subsequent treatment due progressive disease clinically assessed
|
1
|
|
Neoadjuvant chemotherapy
Withdrawal by Subject
|
1
|
|
Neoadjuvant chemotherapy
Progressive disease
|
1
|
|
Neoadjuvant immunotherapy
Progressive disease
|
2
|
|
Neoadjuvant immunotherapy
Withdrawal by Subject
|
1
|
|
Neoadjuvant immunotherapy
General status and respiratory capacity diminution
|
1
|
|
Surgery
lost to follow up
|
7
|
|
Surgery
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MEDI4736
n=67 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Age, Continuous
|
61 years
n=67 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=67 Participants
|
|
Region of Enrollment
Switzerland
|
67 participants
n=67 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: FAS
Measured using the Kaplan-Meier method
Outcome measures
| Measure |
MEDI4736
n=67 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Event-free Survival (EFS) Rate
|
73.4 percentage of participants
Interval 62.7 to 81.5
|
SECONDARY outcome
Timeframe: up to 7 years from registrationMeasured using the Kaplan-Meier method
Outcome measures
| Measure |
MEDI4736
n=67 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Median Event-free Survival (EFS)
|
4.0 years
Interval 2.4 to
Not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: at 1, 2, 3, 4 & 5 years after registrationMeasured using the Kaplan-Meier method
Outcome measures
| Measure |
MEDI4736
n=67 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Overall Survival (OS) Rate
OS rate at 1 year
|
91.0 percentage of participants
Interval 81.0 to 95.8
|
|
Overall Survival (OS) Rate
OS rate at 2 years
|
83.3 percentage of participants
Interval 71.8 to 90.4
|
|
Overall Survival (OS) Rate
OS rate at 3 years
|
70.7 percentage of participants
Interval 58.0 to 80.2
|
|
Overall Survival (OS) Rate
OS rate at 4 years
|
67.5 percentage of participants
Interval 54.6 to 77.5
|
|
Overall Survival (OS) Rate
OS rate at 5 years
|
65.8 percentage of participants
Interval 52.9 to 76.0
|
SECONDARY outcome
Timeframe: After Neoadjuvant Chemotherapy, up to 3 monthsPopulation: patients who received neoadjuvant chemotherapy
Outcome measures
| Measure |
MEDI4736
n=67 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Objective Response (OR) After Neoadjuvant Chemotherapy (FAS)
|
43.3 percentage of participants
Interval 31.2 to 56.0
|
SECONDARY outcome
Timeframe: After Neoadjuvant immunotherapy, up to 3 monthsPopulation: patients who received neoadjuvant immunotherapy
Measured using the Kaplan-Meier method
Outcome measures
| Measure |
MEDI4736
n=62 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Objective Response (OR) After Neoadjuvant Immunotherapy (FAS II)
|
58.1 percentage of participants
Interval 44.8 to 70.5
|
SECONDARY outcome
Timeframe: at 12 monthsPopulation: the 55 resected patients
Outcome measures
| Measure |
MEDI4736
n=55 Participants
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Pathological Responses (pCR)
|
18.2 percentage of participants
Interval 9.1 to 30.9
|
SECONDARY outcome
Timeframe: Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registrationOutcomes are described under "Adverse events".
Outcome measures
Outcome data not reported
Adverse Events
MEDI4736
Serious events: 36 serious events
Other events: 66 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
MEDI4736
n=67 participants at risk
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Cardiac disorders
Heart failure
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Anal ulcer
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Pseudomembranous colitis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Edema limbs
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Fatigue
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Fever
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Bronchial infection
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Catheter related infection
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Infection of unknown origin
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Lung infection
|
9.0%
6/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Mucosal infection
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Sepsis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Wound infection
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Injury, poisoning and procedural complications
Injury to superior vena cava
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Injury, poisoning and procedural complications
Postoperative pulmonary leak and lung infection
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Injury, poisoning and procedural complications
Alt increased, ast increased, ggt increased
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Investigations
Lipase increased
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nsclc (adenocarcinoma)
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
2/67 • Number of events 2 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
3/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Surgical and medical procedures
Adenopathy surgery
|
1.5%
1/67 • Number of events 1 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
Other adverse events
| Measure |
MEDI4736
n=67 participants at risk
Patients whose tumor is deemed resectable at diagnosis will receive 3 cycles (21 days each) of standard chemotherapy with cisplatin/docetaxel followed by 2 cycles (14 days each) of neoadjuvant immunotherapy with MEDI4736 750 mg. Following surgery, patients with complete resection (R0) of their tumor will be administered adjuvant treatment with MEDI4736 750 mg for up to one year or until recurrence, death, unacceptable toxicity or consent withdrawal (whichever occurs first). Patients with incomplete R1/R2 resection, including patients with extracapsular spread of mediastinal lymph node metastases, may undergo standard radiotherapy prior to adjuvant treatment with MEDI4736.
MEDI4736 (anti-PD-L1): fixed dosing 750 mg
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.4%
7/67 • Number of events 12 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Ear and labyrinth disorders
Hearing impaired (Adults)
|
10.4%
7/67 • Number of events 8 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Ear and labyrinth disorders
Tinnitus
|
35.8%
24/67 • Number of events 26 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Ear and labyrinth disorders
Vertigo
|
9.0%
6/67 • Number of events 6 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Endocrine disorders
Hyperthyroidism
|
7.5%
5/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Endocrine disorders
Hypothyroidism
|
6.0%
4/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Eye disorders
Conjunctivitis
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Abdominal pain
|
23.9%
16/67 • Number of events 23 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Constipation
|
37.3%
25/67 • Number of events 38 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Diarrhea
|
62.7%
42/67 • Number of events 71 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.9%
8/67 • Number of events 10 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Mucositis oral
|
11.9%
8/67 • Number of events 12 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Nausea
|
67.2%
45/67 • Number of events 80 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Stomach pain
|
9.0%
6/67 • Number of events 11 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Gastrointestinal disorders
Vomiting
|
43.3%
29/67 • Number of events 47 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Chills
|
9.0%
6/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Edema limbs
|
13.4%
9/67 • Number of events 12 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Fatigue
|
68.7%
46/67 • Number of events 77 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Fever
|
13.4%
9/67 • Number of events 12 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Flu like symptoms
|
10.4%
7/67 • Number of events 9 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Non-cardiac chest pain
|
16.4%
11/67 • Number of events 13 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
General disorders
Pain
|
35.8%
24/67 • Number of events 39 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Bronchial infection
|
7.5%
5/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Lung infection
|
11.9%
8/67 • Number of events 10 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Mucosal infection
|
9.0%
6/67 • Number of events 8 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Rhinitis infective
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Upper respiratory infection
|
7.5%
5/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Infections and infestations
Urinary tract infection
|
11.9%
8/67 • Number of events 16 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Investigations
Creatinine increased
|
10.4%
7/67 • Number of events 12 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Investigations
Neutrophil count decreased
|
10.4%
7/67 • Number of events 11 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Investigations
Platelet count decreased
|
9.0%
6/67 • Number of events 9 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Investigations
White blood cell decreased
|
6.0%
4/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Metabolism and nutrition disorders
Anorexia
|
40.3%
27/67 • Number of events 43 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.9%
8/67 • Number of events 13 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.9%
14/67 • Number of events 24 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.9%
14/67 • Number of events 20 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.4%
7/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.0%
6/67 • Number of events 8 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.5%
5/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.5%
5/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
12/67 • Number of events 15 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
4/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Nervous system disorders
Dizziness
|
9.0%
6/67 • Number of events 7 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Nervous system disorders
Dysesthesia
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Nervous system disorders
Dysgeusia
|
53.7%
36/67 • Number of events 50 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Musculoskeletal and connective tissue disorders
Headache
|
17.9%
12/67 • Number of events 17 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Nervous system disorders
Paresthesia
|
11.9%
8/67 • Number of events 8 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.9%
20/67 • Number of events 27 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Psychiatric disorders
Anxiety
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Psychiatric disorders
Depression
|
7.5%
5/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Psychiatric disorders
Insomnia
|
25.4%
17/67 • Number of events 19 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Renal and urinary disorders
Acute kidney injury
|
6.0%
4/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.8%
30/67 • Number of events 46 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.7%
34/67 • Number of events 44 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
5/67 • Number of events 6 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
4/67 • Number of events 4 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.0%
6/67 • Number of events 6 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.9%
8/67 • Number of events 10 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.7%
36/67 • Number of events 39 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.4%
13/67 • Number of events 15 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.9%
14/67 • Number of events 18 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.9%
8/67 • Number of events 10 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Vascular disorders
Hypertension
|
10.4%
7/67 • Number of events 13 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Vascular disorders
Hypotension
|
6.0%
4/67 • Number of events 5 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
|
Vascular disorders
Thromboembolic event
|
9.0%
6/67 • Number of events 6 • Adverse events were recorded from registration up to 13 months after surgery, up to 17 months. Deaths were reported up to 8 years from registration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place