Trial Outcomes & Findings for Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (NCT NCT03214250)
NCT ID: NCT03214250
Last Updated: 2022-12-23
Results Overview
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Initiation of study drug (or informed consent for SAEs) through 100 days after the last dose of study drug or initiation of a new systemic anti-cancer therapy with a maximum exposure of 34.3 months.
Results posted on
2022-12-23
Participant Flow
Participant milestones
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab
Gemcitabine+Nab-Paclitaxel+nivolumab
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
8
|
8
|
37
|
31
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
8
|
8
|
37
|
31
|
31
|
Reasons for withdrawal
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab
Gemcitabine+Nab-Paclitaxel+nivolumab
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Remains on Study
|
2
|
2
|
0
|
1
|
7
|
5
|
3
|
|
Overall Study
Death
|
5
|
5
|
7
|
4
|
23
|
23
|
24
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
5
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=7 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=7 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=8 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=8 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab
n=37 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/APX005M (0.3 mg/kg)
n=31 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 2: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=31 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
70 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
|
Age, Continuous
|
66.0 years
n=5 Participants
|
64.0 years
n=7 Participants
|
70.0 years
n=5 Participants
|
61.0 years
n=4 Participants
|
64.0 years
n=21 Participants
|
60.0 years
n=8 Participants
|
62 years
n=8 Participants
|
63.0 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
75 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
125 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
108 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
ECOG Performance Score
ECOG Score = 0
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
63 Participants
n=24 Participants
|
|
ECOG Performance Score
ECOG Score = 1
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
|
Cancer Location
Pancreas Body
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
|
Cancer Location
Pancreas Head
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
|
Cancer Location
Pancreas Tail
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
|
Prior Treatment
Prior Chemotherapy · Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Prior Treatment
Prior Chemotherapy · No
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
102 Participants
n=24 Participants
|
|
Prior Treatment
Prior Cancer Surgery · Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Prior Treatment
Prior Cancer Surgery · No
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
94 Participants
n=24 Participants
|
|
Prior Treatment
Prior Radiation · Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Prior Treatment
Prior Radiation · No
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
114 Participants
n=24 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 1
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 2
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 4
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
97 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Initiation of study drug (or informed consent for SAEs) through 100 days after the last dose of study drug or initiation of a new systemic anti-cancer therapy with a maximum exposure of 34.3 months.Population: The DLT-Evaluable Population is defined as all Phase 1b patients who received at least 2 doses of NP, at least 2 doses of Gem, and 1 dose of APX005M during Cycle 1.
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Phase 1b Primary Safety Outcome
Adverse Events (AEs)
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Phase 1b Primary Safety Outcome
Serious Adverse Events (SAEs)
|
4 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Phase 1b Primary Safety Outcome
Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 year from initiation of study therapyPopulation: The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose.
The primary endpoint was the 1-year OS rate of each treatment arm, compared to the historical rate of 35% for gemcitabine and nab-Paclitaxel. OS was defined as the time from treatment initiation until death from any cause. Patients who were not reported as having died at the time of analysis were censored at the most recent contact date. OS and the 1-year OS rate were estimated by the Kaplan-Meier method for each treatment arm. The 1-year OS rate and corresponding one-sided, 95% CI were calculated to determine whether the lower bound of the CI excluded the assumed historical value of 35%. P values were calculated using a one-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%. This study was not powered for statistical comparison between arms.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=34 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=36 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=35 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
1-year Overall Survival Rate
|
0.577 probability
Interval 0.384 to 0.729
|
0.481 probability
Interval 0.309 to 0.634
|
0.413 probability
Interval 0.244 to 0.575
|
—
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 34.3 months.Population: The DLT-Evaluable Population is defined as all Phase 1b patients who received at least 2 doses of NP, at least 2 doses of Gem, and 1 dose of APX005M during Cycle 1.
Phase 1b DLT-Evaluable Population. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=6 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Objective Response Rate (ORR): DLT-Evaluable Population
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 34.3 months.Population: Patients in the DLT-Evaluable Population (defined as all Phase 1b patients who received at least 2 doses of NP, at least 2 doses of Gem, and 1 dose of APX005M during Cycle 1) and who achieved a Partial Response or Complete Response.
DOR was the time from the first tumor assessment demonstrating response until the date of radiographic disease progression. DOR and the CIs were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=4 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=2 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=4 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=4 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Duration of Response (DOR): DLT-Evaluable Population
|
15.51 months
Interval 1.54 to
Some confidence limits are not estimable due to small sample sizes and censoring
|
7.03 months
Interval 6.01 to
Some confidence limits are not estimable due to small sample sizes and censoring
|
9.07 months
Some confidence limits are not estimable due to small sample sizes and censoring
|
10.35 months
Interval 5.32 to
Some confidence limits are not estimable due to small sample sizes and censoring
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.Population: The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose.
Phase 2 Secondary Efficacy Outcome. Disease Control Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as defined by RECIST v1.1.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=34 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=36 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=35 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
73.5 percentage of participants
Interval 55.64 to 87.12
|
77.8 percentage of participants
Interval 60.85 to 89.88
|
68.6 percentage of participants
Interval 50.71 to 83.15
|
—
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or death with a maximum exposure of 24.2 months.Population: The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose.
PFS is defined as the time from treatment initiation until radiographic disease progression or death (whichever occurred first). PFS and the CIs were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=34 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=36 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=35 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
6.37 months
Interval 5.19 to 8.8
|
7.26 months
Interval 5.36 to 9.23
|
6.74 months
Interval 4.17 to 9.79
|
—
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.Population: The Efficacy Population is defined as (1) all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and (2) the 12 DLT-evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose (Arms B2 and C2).
Phase 2 Secondary Efficacy Outcome. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=34 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=36 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=35 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Objective Response Rate (ORR): Efficacy Population
|
50 percentage of participants
Interval 32.43 to 67.57
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
31.4 percentage of participants
Interval 16.85 to 49.29
|
—
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.Population: Patients in the Efficacy Population (defined as all patients who were randomized in Phase 2 and who received at least 1 dose of any study drug and the 12 DLT-Evaluable patients enrolled in Phase 1b at the recommended Phase 2 dose) and who achieved a Partial Response or Complete Response.
DOR was the time from the first tumor assessment demonstrating response until the date of radiographic disease progression. DOR and the CIs were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)
n=17 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)
n=12 Participants
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=11 Participants
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|
|
Duration of Response (DOR): Efficacy Population
|
7.36 months
Interval 2.1 to
The upper confidence limit is not evaluable due to insufficient number of participants with events
|
5.55 months
Interval 3.75 to 7.95
|
7.88 months
Interval 1.91 to
The upper confidence limit is not evaluable due to insufficient number of participants with events
|
—
|
Adverse Events
Gem/NP/Nivolumab
Serious events: 18 serious events
Other events: 36 other events
Deaths: 25 deaths
Gem/NP/APX005M (0.1 mg/kg)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
Gem/NP/APX005M (0.3 mg/kg)
Serious events: 22 serious events
Other events: 36 other events
Deaths: 29 deaths
Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 8 deaths
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
Serious events: 20 serious events
Other events: 35 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Gem/NP/Nivolumab
n=36 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/APX005M (0.1 mg/kg)
n=7 participants at risk
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/APX005M (0.3 mg/kg)
n=37 participants at risk
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=8 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=35 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Acute coronary syndrome
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Ascites
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Bacteraemia
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Cardiac failure
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Chills
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Number of events 3 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Device related infection
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Eye disorders
Diplopia
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Embolism
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Enterocolitis
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Haemoptysis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
IIIrd nerve disorder
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Liver abscess
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Mesenteric venous occlusion
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Myocarditis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Neutropenic sepsis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Pneumonia staphylococcal
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pseudocellulitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Number of events 3 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Pyrexia
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Number of events 3 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Number of events 4 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.7%
1/37 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Sepsis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Number of events 3 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Septic shock
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Number of events 3 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Staphylococcal infection
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Systemic inflammatory response syndrome
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Tachycardia
|
2.8%
1/36 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Number of events 2 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
2.9%
1/35 • Number of events 1 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
Other adverse events
| Measure |
Gem/NP/Nivolumab
n=36 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/APX005M (0.1 mg/kg)
n=7 participants at risk
Gemcitabine+Nab-Paclitaxel+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/APX005M (0.3 mg/kg)
n=37 participants at risk
Gemcitabine+Nab-Paclitaxel+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/Nivolumab/APX005M (0.1 mg/kg)
n=8 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.1 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)
n=35 participants at risk
Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M (0.3 mg/kg)
APX005M: Administer intravenously once every 28-day Cycle
Nivolumab: Administer intravenously twice every 28-day cycle
Nab-Paclitaxel: Administer intravenously on 3 times every 28-day cycle
Gemcitabine: Administer intravenously 3 times every 28-day cycle
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Abdominal distension
|
13.9%
5/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
22.9%
8/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
15/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
40.5%
15/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
51.4%
18/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
19.4%
7/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
18/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
59.5%
22/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
65.7%
23/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.9%
14/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
45.9%
17/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
34.3%
12/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Anaemia
|
61.1%
22/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
100.0%
7/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
59.5%
22/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
50.0%
4/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
51.4%
18/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Anxiety
|
25.0%
9/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
24.3%
9/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Aspartate aminotransferase increased
|
52.8%
19/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
67.6%
25/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
60.0%
21/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Asthenia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Autoimmune neuropathy
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
21.6%
8/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
22.9%
8/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
9/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
43.2%
16/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
40.0%
14/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Blood bilirubin increased
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
34.3%
12/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Blood creatinine increased
|
13.9%
5/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Candida infection
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Cellulitis
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Chest discomfort
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Chest pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Chills
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
71.4%
5/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
81.1%
30/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
75.0%
6/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
77.1%
27/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Constipation
|
44.4%
16/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
59.5%
22/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
50.0%
4/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.1%
13/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
15/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
32.4%
12/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
40.0%
14/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Cystitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
71.4%
5/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
31.4%
11/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
61.1%
22/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
56.8%
21/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
15/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
9/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
21.6%
8/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Depression
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
52.8%
19/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
54.1%
20/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
60.0%
21/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Eye disorders
Diplopia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Dizziness
|
19.4%
7/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Eye disorders
Dry eye
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
20.0%
7/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.1%
13/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.8%
14/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.1%
13/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Early satiety
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
8/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Eructation
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Face oedema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Fatigue
|
75.0%
27/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
100.0%
7/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
78.4%
29/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
62.5%
5/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
82.9%
29/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Flushing
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Gait disturbance
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Generalised oedema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Headache
|
22.2%
8/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
32.4%
12/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
50.0%
4/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Hot flush
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Hypertension
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
24.3%
9/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
19.4%
7/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.9%
5/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
32.4%
12/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Hypotension
|
22.2%
8/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
29.7%
11/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
34.3%
12/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Influenza like illness
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Infusion site pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Insomnia
|
19.4%
7/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
27.0%
10/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
6/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
24.3%
9/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Malaise
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Medical device site joint swelling
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Mucosal inflammation
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
27.0%
10/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
10/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
72.2%
26/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
85.7%
6/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
89.2%
33/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
62.5%
5/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
82.9%
29/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Neuropathy peripheral
|
27.8%
10/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
85.7%
6/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
45.9%
17/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
50.0%
4/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
8/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
32.4%
12/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Neutrophil count decreased
|
36.1%
13/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
40.5%
15/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
15/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Oedema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Oedema peripheral
|
41.7%
15/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
59.5%
22/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.1%
13/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Otitis media
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Pain
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Palpitations
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Paronychia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
8/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
20.0%
7/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Peripheral swelling
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Platelet count decreased
|
36.1%
13/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
35.1%
13/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
48.6%
17/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Platelet count increased
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Presyncope
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.9%
5/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
43.2%
16/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.1%
13/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
General disorders
Pyrexia
|
44.4%
16/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
78.4%
29/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
75.0%
6/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
68.6%
24/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.2%
17/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
4/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
29.7%
11/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
50.0%
4/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
48.6%
17/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
3/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.1%
3/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
13.9%
5/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Cardiac disorders
Tachycardia
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
9/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
29.7%
11/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.0%
2/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
15/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Septic shock
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Tremor
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
16.2%
6/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
4/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
13.5%
5/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
25.7%
9/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Eye disorders
Vision blurred
|
5.6%
2/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
28.6%
2/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
5/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
14/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
42.9%
3/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
62.2%
23/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
57.1%
20/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Weight decreased
|
30.6%
11/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
10.8%
4/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
37.5%
3/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
11.4%
4/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
Weight increased
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.4%
2/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Investigations
White blood cell count decreased
|
27.8%
10/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
18.9%
7/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
17.1%
6/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
8.6%
3/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
5.7%
2/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/36 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
14.3%
1/7 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/37 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
12.5%
1/8 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
0.00%
0/35 • Adverse events were reported until 100 days after the last dose of study drug had been administered with a maximum exposure of 34.3 months.
Safety analysis was conducted on all Phase 1b and Phase 2 patients who received at least one dose of any study drug. For safety analyses, patients were grouped according to the study treatment actually received ('as treated'). Specifically, two phase 2 patients were randomly allocated to Gem/NP/Nivolumab/APX005M but only received doses of Gem, NP, and Nivolumab (that is, APX005M was not received); these two patients were grouped as Gem/NP/APX005M for safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy \[PICI\] confirms in writing there will not be a multi-site Study publication.
- Publication restrictions are in place
Restriction type: OTHER