Trial Outcomes & Findings for Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC (NCT NCT03057106)
NCT ID: NCT03057106
Last Updated: 2025-08-29
Results Overview
time from randomization to the date of death
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
33 months
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Durvalumab and Tremelimumab
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
148
|
|
Overall Study
COMPLETED
|
149
|
148
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC
Baseline characteristics by cohort
| Measure |
Durvalumab and Tremelimumab
n=150 Participants
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=151 Participants
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
86 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Age, Categorical
Age · >=65 years
|
64 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Smoking history
Never smoke
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Smoking history
Ever smoked
|
136 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Histology type
Non-squamous
|
123 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Histology type
Squamous
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 33 monthsPopulation: ITT population, included patients who refused the study treatments (4 patients)
time from randomization to the date of death
Outcome measures
| Measure |
Durvalumab and Tremelimumab
n=150 Participants
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=151 Participants
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Overall Survival
|
14.1 Months
Interval 10.6 to 18.3
|
16.6 Months
Interval 12.6 to 19.1
|
SECONDARY outcome
Timeframe: 33 monthsPopulation: ITT population, included the 4 patents who refused study treatments.
time from randomization to the date of the first documented disease progression. Progression was defined as: at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥5 mm, or appearance of new lesions.
Outcome measures
| Measure |
Durvalumab and Tremelimumab
n=150 Participants
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=151 Participants
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Progression-free Survival Using RECIST 1.1
|
3.22 Months
Interval 2.73 to 5.13
|
7.72 Months
Interval 5.52 to 8.54
|
SECONDARY outcome
Timeframe: 33 monthsPopulation: ITT population
proportion of patients with a documented complete response, partial response (CR + PR) based on iRECIST criteria. The primary estimate of ORR will be based on all patients randomized, and compared using Cochran- Mantel-Haeszel test stratified by stratification factors at randomization between the study new treatment and the standard control arms.
Outcome measures
| Measure |
Durvalumab and Tremelimumab
n=150 Participants
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=151 Participants
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Objective Response Rate Using RECIST 1.1 and iRECIST
Stable Disease
|
47 Participants
|
53 Participants
|
|
Objective Response Rate Using RECIST 1.1 and iRECIST
Partial Response
|
44 Participants
|
64 Participants
|
|
Objective Response Rate Using RECIST 1.1 and iRECIST
Progressive Disease
|
53 Participants
|
25 Participants
|
|
Objective Response Rate Using RECIST 1.1 and iRECIST
Inevaluable
|
6 Participants
|
9 Participants
|
Adverse Events
Durvalumab and Tremelimumab
Serious events: 84 serious events
Other events: 149 other events
Deaths: 80 deaths
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
Serious events: 102 serious events
Other events: 148 other events
Deaths: 77 deaths
Serious adverse events
| Measure |
Durvalumab and Tremelimumab
n=149 participants at risk
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=148 participants at risk
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.7%
7/148 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Asystole
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Atrial flutter
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Cardiac arrest
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Pericardial tamponade
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Colitis
|
9.4%
14/149 • Number of events 14 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
16/149 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.8%
10/148 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
3.4%
5/148 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Death NOS
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Fatigue
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Fever
|
3.4%
5/149 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Flu like symptoms
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Infusion related reaction
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Other general disorders, administration site conditions
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Pain
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Sudden death NOS
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Immune system disorders
Other immune system disorders
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.1%
6/148 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Joint infection
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Lung infection
|
7.4%
11/149 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Other infections and infestations
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.1%
6/148 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Sepsis
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Skin infection
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.1%
6/148 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Creatinine increased
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
GGT increased
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Lipase increased
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.8%
10/148 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Serum amylase increased
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Weight loss
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
White blood cell decreased
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
8.7%
13/149 • Number of events 13 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
12.2%
18/148 • Number of events 18 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Dizziness
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Dysesthesia
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Edema cerebral
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Facial nerve disorder
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Headache
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Lethargy
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Other nervous system disorders
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Radiculitis
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Seizure
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Stroke
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Confusion
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Delirium
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.7%
4/148 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.7%
7/149 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.7%
7/148 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
2.0%
3/148 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
5/149 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.7%
7/148 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.00%
0/148 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Hypotension
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
1.4%
2/148 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Other vascular disorders
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/149 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
0.68%
1/148 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Thromboembolic event
|
4.7%
7/149 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.1%
9/148 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
Other adverse events
| Measure |
Durvalumab and Tremelimumab
n=149 participants at risk
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
|
Platinum Based Chemotherapy + Durvalumab + Tremelimumab
n=148 participants at risk
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Durvalumab: MEDI4736
Tremelimumab: Tremelimumab
Platinum-Based Drug: Pemetrexed, cisplatin, carboplatin or gemcitibine
|
|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Ear and labyrinth disorders
Ear pain
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Endocrine disorders
Hypothyroidism
|
12.8%
19/149 • Number of events 19 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
12.2%
18/148 • Number of events 18 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Eye disorders
Blurred vision
|
6.7%
10/149 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.8%
10/148 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Eye disorders
Other eye disorders
|
3.4%
5/149 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Eye disorders
Watering eyes
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
13.5%
20/148 • Number of events 20 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
26/149 • Number of events 26 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
19.6%
29/148 • Number of events 29 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Bloating
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Colitis
|
7.4%
11/149 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
40.3%
60/149 • Number of events 60 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
56.8%
84/148 • Number of events 84 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
33.6%
50/149 • Number of events 50 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
48.6%
72/148 • Number of events 72 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dry mouth
|
10.1%
15/149 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
12.8%
19/148 • Number of events 19 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
8/149 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
12.2%
18/148 • Number of events 18 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.1%
9/148 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.7%
13/149 • Number of events 13 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
9.5%
14/148 • Number of events 14 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.1%
12/149 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
14.9%
22/148 • Number of events 22 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
40.3%
60/149 • Number of events 60 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
68.2%
101/148 • Number of events 101 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
36/149 • Number of events 36 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
36.5%
54/148 • Number of events 54 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Chills
|
5.4%
8/149 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Edema limbs
|
14.1%
21/149 • Number of events 21 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
28.4%
42/148 • Number of events 42 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Fatigue
|
70.5%
105/149 • Number of events 105 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
84.5%
125/148 • Number of events 125 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Fever
|
14.8%
22/149 • Number of events 22 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
18.9%
28/148 • Number of events 28 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Flu like symptoms
|
7.4%
11/149 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Non-cardiac chest pain
|
20.8%
31/149 • Number of events 31 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
16.2%
24/148 • Number of events 24 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
General disorders
Pain
|
16.1%
24/149 • Number of events 24 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
20.3%
30/148 • Number of events 30 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Immune system disorders
Other immune system disorders
|
3.4%
5/149 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Lung infection
|
8.1%
12/149 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Other infections and infestations
|
8.1%
12/149 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.7%
7/148 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Skin infection
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Upper respiratory infection
|
18.1%
27/149 • Number of events 27 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
12.2%
18/148 • Number of events 18 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.8%
16/148 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.8%
10/148 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Creatinine increased
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Weight gain
|
2.0%
3/149 • Number of events 3 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Investigations
Weight loss
|
27.5%
41/149 • Number of events 41 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
25.0%
37/148 • Number of events 37 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.6%
68/149 • Number of events 68 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
52.7%
78/148 • Number of events 78 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.1%
15/149 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
5/149 • Number of events 5 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
9/149 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.1%
6/148 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.8%
25/149 • Number of events 25 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
14.9%
22/148 • Number of events 22 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
38.3%
57/149 • Number of events 57 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
37.2%
55/148 • Number of events 55 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
18/149 • Number of events 18 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.7%
16/149 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.8%
16/148 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.1%
9/148 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.0%
9/149 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
11.5%
17/148 • Number of events 17 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
9/149 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.8%
10/148 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.1%
12/149 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
5.4%
8/149 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.1%
33/149 • Number of events 33 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
27.7%
41/148 • Number of events 41 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.4%
11/149 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
4.7%
7/148 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Dizziness
|
10.7%
16/149 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
21.6%
32/148 • Number of events 32 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
13/149 • Number of events 13 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
15.5%
23/148 • Number of events 23 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Headache
|
19.5%
29/149 • Number of events 29 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
27.7%
41/148 • Number of events 41 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Paresthesia
|
6.0%
9/149 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.7%
13/149 • Number of events 13 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
20.3%
30/148 • Number of events 30 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Anxiety
|
17.4%
26/149 • Number of events 26 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
16.2%
24/148 • Number of events 24 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Confusion
|
2.7%
4/149 • Number of events 4 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.1%
9/148 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Depression
|
10.7%
16/149 • Number of events 16 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Psychiatric disorders
Insomnia
|
30.9%
46/149 • Number of events 46 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
37.8%
56/148 • Number of events 56 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.3%
2/149 • Number of events 2 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.6%
65/149 • Number of events 65 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
53.4%
79/148 • Number of events 79 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
62.4%
93/149 • Number of events 93 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
64.2%
95/148 • Number of events 95 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
7.4%
11/148 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
6/149 • Number of events 6 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
6.1%
9/148 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
7.4%
11/149 • Number of events 11 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.1%
12/148 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.8%
19/149 • Number of events 19 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
16.2%
24/148 • Number of events 24 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.67%
1/149 • Number of events 1 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
5.4%
8/148 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
8/149 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
15.5%
23/148 • Number of events 23 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
10/149 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
6.7%
10/149 • Number of events 10 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
13.5%
20/148 • Number of events 20 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.2%
39/149 • Number of events 39 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
29.7%
44/148 • Number of events 44 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.4%
8/149 • Number of events 8 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.2%
42/149 • Number of events 42 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
30.4%
45/148 • Number of events 45 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Hypertension
|
6.0%
9/149 • Number of events 9 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
10.1%
15/148 • Number of events 15 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Hypotension
|
4.7%
7/149 • Number of events 7 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
8.8%
13/148 • Number of events 13 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
|
Vascular disorders
Thromboembolic event
|
8.1%
12/149 • Number of events 12 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
9.5%
14/148 • Number of events 14 • 33 months
Adverse events graded according to CTCAE Version 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place