Trial Outcomes & Findings for Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer (NCT NCT00874848)
NCT ID: NCT00874848
Last Updated: 2016-11-29
Results Overview
Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Results posted on
2016-11-29
Participant Flow
A randomized, Simon 2-stage flexible design with 22 patients enrolled in stage 1 and 68 additional patients in stage 2, for a total of 90 subjects (60 in the Imprime PGG arm and 30 in the Control arm) enrolled competitively across US and German clinical sites. First subject enrolled: 17 Aug 2009 Last subject last visit: 15 Nov 2012
A total of 90 participants enrolled, 88 participants received at least one dose of study treatment, and 2 participants did not receive any study treatment.
Participant milestones
| Measure |
Imprime PGG Arm
Imprime PGG® infusion:
4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;
Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor.
|
Control Arm
Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
29
|
|
Overall Study
Discontinued
|
59
|
28
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
59
|
28
|
Reasons for withdrawal
| Measure |
Imprime PGG Arm
Imprime PGG® infusion:
4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;
Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor.
|
Control Arm
Cetuximab infusion:
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;
Paclitaxel infusion:
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin infusion:
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
2
|
|
Overall Study
Progressive neoplastic disease
|
38
|
18
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Noncompliance
|
1
|
1
|
|
Overall Study
Failure to comply with protocol
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Imprime PGG Arm
n=59 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=29 Participants
Cetuximab + Paclitaxel/Carboplatin
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
60.45 Years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
56 participants
n=5 Participants
|
29 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
55 participants
n=5 Participants
|
27 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
ECOG
Score = 0
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
ECOG
Score = 1
|
38 participants
n=5 Participants
|
18 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
ECOG
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline Height
|
171.1 cm
STANDARD_DEVIATION 7.51 • n=5 Participants
|
170.0 cm
STANDARD_DEVIATION 8.90 • n=7 Participants
|
170.8 cm
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Baseline Weight
|
76.2 kg
STANDARD_DEVIATION 16.52 • n=5 Participants
|
72.8 kg
STANDARD_DEVIATION 12.19 • n=7 Participants
|
75.0 kg
STANDARD_DEVIATION 15.24 • n=5 Participants
|
|
Baseline Body Mass Index
|
25.9 kg/m^2
STANDARD_DEVIATION 4.95 • n=5 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 3.00 • n=7 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 4.40 • n=5 Participants
|
|
Time from Initial Tumor Diagnosis
|
0.9 months
STANDARD_DEVIATION 1.04 • n=5 Participants
|
0.9 months
STANDARD_DEVIATION 1.53 • n=7 Participants
|
0.9 months
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Prior Cancer Treatment
Radiotherapy
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Prior Cancer Treatment
Surgery
|
23 participants
n=5 Participants
|
13 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Prior Cancer Treatment
Chemotherapy
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 monthsPopulation: The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations \& received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, \& had an evaluable baseline scan \& at least one evaluable post-baseline response based on modified RECIST v1.0.
Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
Outcome measures
| Measure |
Imprime PGG Arm
n=41 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=26 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Number of participants with best response of CR
|
0 participants
|
0 participants
|
|
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Number of participants with best response of PR
|
15 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From the time of randomization to death, subject being lost to follow-up or study completionPopulation: The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.
Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.
Outcome measures
| Measure |
Imprime PGG Arm
n=59 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=29 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Overall Survival (OS) in Each Study Arm Based on the Safety Population
|
10.3 months
Interval 8.6 to 15.1
|
12.4 months
Interval 9.3 to 17.4
|
SECONDARY outcome
Timeframe: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 monthsPopulation: The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations \& received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, \& had an evaluable baseline scan \& at least one evaluable post-baseline response based on modified RECIST v1.0.
The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
Outcome measures
| Measure |
Imprime PGG Arm
n=41 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=26 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
|
35 participants
|
21 participants
|
SECONDARY outcome
Timeframe: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 monthsPopulation: The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations \& received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, \& had an evaluable baseline scan \& at least one evaluable post-baseline response based on modified RECIST v1.0.
The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
Outcome measures
| Measure |
Imprime PGG Arm
n=41 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=26 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Number of participants with best response of CR
|
0 participants
|
0 participants
|
|
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Number of participants with best response of PR
|
15 participants
|
6 participants
|
|
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Number of participants with best response of SD
|
20 participants
|
15 participants
|
SECONDARY outcome
Timeframe: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 monthsPopulation: The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations \& received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, \& had an evaluable baseline scan \& at least one evaluable post-baseline response based on modified RECIST v1.0.
The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
Outcome measures
| Measure |
Imprime PGG Arm
n=15 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=6 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
|
4.4 months
Interval 2.8 to 6.5
|
4.1 months
Interval 1.4 to 5.4
|
SECONDARY outcome
Timeframe: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 monthsPopulation: The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations \& received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, \& had an evaluable baseline scan \& at least one evaluable post-baseline response based on modified RECIST v1.0.
Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.
Outcome measures
| Measure |
Imprime PGG Arm
n=41 Participants
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=26 Participants
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
|
6.4 months
Interval 4.3 to 8.3
|
6.0 months
Interval 4.3 to 7.1
|
Adverse Events
Imprime PGG Arm
Serious events: 37 serious events
Other events: 59 other events
Deaths: 0 deaths
Control Arm
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imprime PGG Arm
n=59 participants at risk
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=29 participants at risk
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Atrial flutter
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Cardiac failure acute
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Tachyarrhythmia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Tachycardia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Asthenia
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Chills
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Death
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Disease progression
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
General physical health deterioration
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Infusion site extravasation
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Immune system disorders
Anaphylactic shock
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Erysipelas
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Anal abscess
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Diverticulitis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Neutropenic sepsis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Urosepsis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Blood glucose increased
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Epilepsy
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Vascular disorders
Hypotension
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Vascular disorders
Vascular occulsion
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
Other adverse events
| Measure |
Imprime PGG Arm
n=59 participants at risk
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
|
Control Arm
n=29 participants at risk
Cetuximab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
37.3%
22/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
48.3%
14/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.0%
13/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
31.0%
9/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
24.1%
7/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Cardiac disorders
Tachycardia
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Nausea
|
42.4%
25/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
41.4%
12/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.7%
24/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
31.0%
9/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Constipation
|
18.6%
11/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
34.5%
10/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
11/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Fatigue
|
50.8%
30/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
58.6%
17/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Mucosal inflammation
|
22.0%
13/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
20.7%
6/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Chest pain
|
16.9%
10/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Chills
|
13.6%
8/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Pyrexia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
27.6%
8/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Oedema peripheral
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Asthenia
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
General physical health deterioration
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
General disorders
Chest discomfort
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Immune system disorders
Hypersensitivity
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Paronychia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Bronchitis
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Cystitis
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Folliculitis
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Infection
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Pneumonia
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Haemoglobin decreased
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Amylase increased
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Blood magnesium decreased
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Blood phosphorus decreased
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Weight decreased
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Investigations
Body temperature increased
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.0%
13/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
24.1%
7/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.6%
11/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
20.7%
6/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.9%
10/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Polyneuropathy
|
27.1%
16/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
31.0%
9/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Paraesthesia
|
11.9%
7/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
31.0%
9/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Dizziness
|
13.6%
8/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
20.7%
6/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Headache
|
11.9%
7/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Dysgeusia
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Ageusia
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Psychiatric disorders
Insomnia
|
11.9%
7/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Psychiatric disorders
Sleep disorder
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Renal and urinary disorders
Renal pain
|
1.7%
1/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.3%
12/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
37.9%
11/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.9%
10/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
34.5%
10/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
20.7%
6/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.9%
7/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.5%
5/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
2/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.5%
28/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
65.5%
19/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.3%
22/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
44.8%
13/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.3%
12/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
17.2%
5/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.3%
9/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
13.8%
4/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
18.6%
11/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
6/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
10.3%
3/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
6.9%
2/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Vascular disorders
Hypotension
|
6.8%
4/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
3.4%
1/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
|
Vascular disorders
Thrombosis
|
5.1%
3/59 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
0.00%
0/29 • Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
|
Additional Information
Jamie Lowe, Vice President, Clinical Development
Biothera
Phone: 651-256-4653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place