Trial Outcomes & Findings for A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer (NCT NCT02259582)
NCT ID: NCT02259582
Last Updated: 2020-09-09
Results Overview
Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.
Results posted on
2020-09-09
Participant Flow
Participant milestones
| Measure |
Placebo/Placebo Arm (Arm 1)
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
29
|
|
Overall Study
COMPLETED
|
9
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
21
|
Reasons for withdrawal
| Measure |
Placebo/Placebo Arm (Arm 1)
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
14
|
15
|
17
|
|
Overall Study
Lack of Subject Adherence to Protocol
|
1
|
1
|
1
|
Baseline Characteristics
A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Placebo/Placebo Arm (Arm 1)
n=25 Participants
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
n=28 Participants
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
n=29 Participants
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
66 years
n=7 Participants
|
61 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
Outcome measures
| Measure |
Placebo/Placebo Arm (Arm 1)
n=25 Participants
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
n=28 Participants
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
n=29 Participants
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
|---|---|---|---|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Partial response (PR)
|
13 Participants
|
10 Participants
|
6 Participants
|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Stable disease (SD)
|
10 Participants
|
14 Participants
|
15 Participants
|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Progressive disease (PD)
|
2 Participants
|
4 Participants
|
5 Participants
|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Not evaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Missing
|
0 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
Placebo/Placebo Arm (Arm 1)
Serious events: 6 serious events
Other events: 25 other events
Deaths: 1 deaths
Demcizumab/Placebo Arm (Arm 2)
Serious events: 11 serious events
Other events: 28 other events
Deaths: 2 deaths
Demcizumab/Demcizumab Arm (Arm 3)
Serious events: 15 serious events
Other events: 29 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo/Placebo Arm (Arm 1)
n=25 participants at risk
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
n=28 participants at risk
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
n=29 participants at risk
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Cervical cord compression
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
General physical health deterioration
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Performance status decreased
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Platelet count decreased
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Dehydration
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Lung infection
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
Other adverse events
| Measure |
Placebo/Placebo Arm (Arm 1)
n=25 participants at risk
Placebo plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Placebo Arm (Arm 2)
n=28 participants at risk
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), placebo plus pemetrexed (4 cycles)
|
Demcizumab/Demcizumab Arm (Arm 3)
n=29 participants at risk
Demcizumab plus pemetrexed and carboplatin (4 cycles), pemetrexed (4 cycles), demcizumab plus pemetrexed (4 cycles)
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
60.0%
15/25 • Number of events 15 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
39.3%
11/28 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
37.9%
11/29 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
9/25 • Number of events 9 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
28.6%
8/28 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
37.9%
11/29 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
21.4%
6/28 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
44.8%
13/29 • Number of events 13 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Eye disorders
Dry eye
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
72.0%
18/25 • Number of events 18 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
64.3%
18/28 • Number of events 18 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
48.3%
14/29 • Number of events 14 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
13.8%
4/29 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
25.0%
7/28 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
20.7%
6/29 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
20.7%
6/29 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
39.3%
11/28 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
31.0%
9/29 • Number of events 9 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
13.8%
4/29 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Dizziness
|
32.0%
8/25 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
32.1%
9/28 • Number of events 9 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Dysgeusia
|
32.0%
8/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Eye disorders
Lacrimation increased
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.9%
5/28 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Vascular disorders
Hypertension
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
50.0%
14/28 • Number of events 14 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
41.4%
12/29 • Number of events 12 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Vascular disorders
Hypotension
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Fatigue
|
60.0%
15/25 • Number of events 15 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
57.1%
16/28 • Number of events 16 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
41.4%
12/29 • Number of events 12 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Asthenia
|
32.0%
8/25 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
35.7%
10/28 • Number of events 28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
31.0%
9/29 • Number of events 29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Pyrexia
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
21.4%
6/28 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
31.0%
9/29 • Number of events 9 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Oedema peripheral
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
General disorders
Malaise
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Psychiatric disorders
Insomnia
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.9%
5/28 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
24.1%
7/29 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Psychiatric disorders
Anxiety
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
28.6%
8/28 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
20.7%
6/29 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Alanine aminotransferase increased
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Platelet count decreased
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Neutrophil count decreased
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Blood creatinine increased
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Investigations
Weight decreased
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Cardiac disorders
Sinus tachycardia
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
25.0%
7/28 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
31.0%
9/29 • Number of events 9 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
28.6%
8/28 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/28 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/25 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
14.3%
4/28 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
44.0%
11/25 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
39.3%
11/28 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
27.6%
8/29 • Number of events 8 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
5/25 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
21.4%
6/28 • Number of events 6 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.2%
5/29 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Nervous system disorders
Headache
|
28.0%
7/25 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
39.3%
11/28 • Number of events 11 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
24.1%
7/29 • Number of events 7 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
17.9%
5/28 • Number of events 5 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
0.00%
0/29 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
13.8%
4/29 • Number of events 4 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
10.7%
3/28 • Number of events 3 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected at every weekly study visit from randomization until 30 days after the termination visit for up to approximately 26 months.
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment arm.
|
Additional Information
Manager, Regulatory Affairs
OncoMed Pharmaceuticals, Inc.
Phone: 6509958322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place